Modified devices may not perform as intended and could result in patient injury. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. Absent talus (requiring talocalcaneal arthrodesis). Reusable instruments should be placed in suitable packaging for the sterilization process (i.e. The DynaNail Mini Fusion System components manufactured by MedShape must not be used in conjunction with screws, wire bands, or other metallic devices manufactured by any other manufacturer, as component parts may not be compatible. Potential adverse effects resulting from the use of the DynaNail TTC Fusion System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision or removal surgery, and/or amputation of the limb. Reusable instruments should be placed in suitable packaging for the sterilization process (i.e. Sensitivity, allergies or other reaction to the device material. Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of implantable DynaNail Mini Fusion System components. Featuring MedShape's patented superelastic nickel titanium (NiTiNOL) technology, the DynaNail Mini is the first orthopaedic device designed specifically for subtalar fusion that offers maintained . Drill a lateral-to-medial hole into the calcaneus through the proximal calcaneal hole across the DynaNail implant and insert a 5mm Headed Cortical Screw1. Ft. White Top Load Washer User Guide, Fujifilm Finepix A900 9MP Digital Camera Owners Guide, LG HU80KA Smart CineBeam DLP Projector Owners Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. Rinse parts under warm or hot flowing, potable water for a minimum of one (1) minute including direct contact with all surfaces for at least ten (10) seconds. Patients with significant tibial malalignment (>10 degrees in either sagittal or coronal plane). Tibiotalocalcaneal Arthrodesis with Intramedullary Nails Mechanobiological Background and Evolution of Compressive Technology. Please remove any damaged device or instrument from use and call your DJO sales representative for a replacement. Drug and/or alcohol and/or smoke addiction and/or abuse. Offered in 60 100 mm lengths (in increments of 10 mm) to complement diverse patient anatomies. Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. Indicates the date after which the medical device is not to be used. Contact MedShape customer service for any replacements. Visually inspect all instruments to ensure that all blood, saline, and traces of tissue are removed and instruments are visibly clean.Refer to Table A for further cleaning instructions. DynaNail Mini is a trademark of MedShape, Inc. DynaNail and DynaClip are registered trademarks of MedShape, Inc. 1 Dupont KM, Shibuya N, Bariteau JT. The patient should be provided with detailed written instructions regarding postoperative care and theuse and limitations of the device. When evaluating patients for implantation using the DynaNail TTC Fusion System, always consider the patients weight, occupation, activity level, and the presence of any degenerative disease. Follow the manufacturers instructions for mixing, preparing, and using such detergents. Scanning a patient who has this device may result in patient injury. STERILIZATIONRecommended sterilization methods have been validated to sterility assurance levels (SAL) in compliance with federal and international standards. Extreme care must be taken when following the technique for removal of the device. the presence of protein and the instrument should be re-cleaned. The latest addition to DJO's robust suite of foot and ankle products and an expansion of the DynaNail Mini line, the system leverages MedShape's proven active, adaptive healing technology 1 . Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. The adequacy of any healthcare facility sterilization procedure must be suitably tested. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury. Prolonged exposure to saline may result in corrosion of stainless steel instruments. Hear from patient Teri Sutherland about her experience and recovery after undergoing a procedure with MedShape's DynaNail Mini. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. Containment devices can be stacked for storage. If evidence suggests a loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities. and sterilized prior to surgical use. ATLANTA, Sept. 3, 2019 /PRNewswire/ -- MedShape Inc., the industry leader in orthopedic devices using advanced functional materials, announced today the launch of the DynaNail Mini Fusion System. Once the DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws have been removed from the packaging, the device should be either used or discarded. Moist heat/steam is the only method that has been validated for reprocessing by DJO. Refer to Table A for manual cleaning steps. Ideally, all components should be cleaned within 30 minutes, and after no more than 4 hours, of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments, or other organic debris to dry on the instrument prior to cleaning. Extreme care must be taken when following the technique for removal of the device. NOTE: Indicates the manufacturers batch code so that the batch or lot can be identified. Do not use device if it appears defective, damaged or otherwise compromised.The DynaNail Helix Fixation System is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. The surgical procedure will involve subtalar (talocalcaneal) joint preparation through a lateral approach. Indicates the need for the user to consult the instructions for use. In the absence of a bursa or pain, removal of the implant in elderly or debilitated patients is not recommended. The DynaNail Mini Fusion System features MedShape's patented superelastic nickel . Using the Posterior-Anterior Targeting Arm with the Deployment Frame1, drill a posterior-to-anterior hole into the calcaneus through the distal calcaneal hole in the DynaNail Implant and insert a 5mm Headless PA Screw. Indicates a medical device that has been sterilized using irradiation. Sensitivity, allergies, or other reactions to the device material. The DynaNail TTC Fusion Nail is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. CONTRAINDICATIONS Patients with an active local or systemic infection. Handling of the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. Pain, discomfort or abnormal sensations due to presence of the implant. Your email address will not be published. Once the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer have been removed from the packaging, the devices should be either used or discarded. The DynaNail Instrument Caddy is designed to hold the DynaNail Deployment Frame and all of the Ancillary Surgical Instruments during sterilization. Return Conditions:In the event, the device must be returned for any reason, return the product in the original packaging. Ideally, all components should be cleaned within 30 minutes and after no more than 4 hours, of use to minimize the potential for saline, blood, body fluids, tissue, bone fragments or other organic debris to dry on the instrument prior to cleaning. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. Serious postoperative complications may occur from the use of the implant in a patient who: The DynaNail TTC Fusion Nail has not been evaluated for safety and compatibility in the MR environment. Avoid contacting the implant with other tools or materials that could notch, scratch, or otherwise damage the implant surface. Visually inspect all instruments for any remaining debris prior to sterilization. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). 4. If sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use. Rehabilitation, pain management and healing. Loss of fixation in bone attribute to nonunion, osteoporosis and/or markedly unstable comminuted fractures. Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. Never attempt a surgical procedure with defective, damaged, or otherwise compromised instruments or implants. The patient should be advised that on compliance with postoperative instructions could lead to loosening, bending or breakage of the implant, requiring revision surgery to remove the device. Modified devices may not perform as intended and could result in patient injury. Correct selection of the DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer is extremely important. Patients with severe peripheral vascular disease. Subtalar fusion surgery is performed to relieve pain and correct severe foot deformity by achieving a solid bony union. Demonstrates physiologic or anatomic anomalies. DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile : Code Information: Model No. Recommended Steam Sterilization ParametersTime and temperature parameters required for sterilization vary according to type of sterilizer and cycle design. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility.Any recommendations provided herein are provided as general guidelines only. Tissue reactions including macrophage and foreign body reactions adjacent to implants. The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be best for each individual patient. Call your MedShape sales representative for a replacement. Place the End Cap into the distal end of the DynaNail Implant and close the incision per surgeon preference. on DYNANAIL TTC Fusion System Instructions. Has immunological responses, sensitization, or hypersensitivity to foreign materials. If evidence suggests loosening of the implant (particularly pain and/or progressive changes in the radiographs), an intensified schedule of check-ups is advised and new warnings and instructions to the patient may be necessary to further restrict activities. Turn the Manual Compression Knob on the Deployment Frame to apply external manual compression. The patient should be encouraged to receive prompt medical attention for any infection that may occur, either at the surgery site or elsewhere in the body. Careful preoperative planning must be conducted based on radiographic findings. Comment * document.getElementById("comment").setAttribute("id","aa0031aceadd6ff5ff5e8761e89208bc");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. Do not modify the implant. Drying times vary according to load size and should be increased for larger loads. Lester ELECTRICAL ChargerConnect App User Guide, mXion PWD 2-Channel Function Decoder User Manual, amber connect ANC200 Instant C200 Cigarette Lighter GNSS Tracker User Guide, mXion RD6 6-Channel Relay Decoder User Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. Validated exposure time required to achieve a 10-6 sterility assurance level (SAL). Packaged and sterilized instruments should be stored in an area that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity. Rinse parts under warm or hot flowing, sterile water for a minimum of one (1) minute including direct contact with all surfaces for at least ten (10) seconds.8.Repeat rinsing step using distilled, reverse osmosis or deionized water. 1(5). In order to make an informed decision, the patient should clearly understand all applicable warnings, precautions, possible intraoperative and postoperative complications and possible adverse effects associated with the surgical procedure and implantation of the device. Visually inspect all instruments for damage and wear. The worldwide leading provider of diabetic footwear. pipe cleaner, or appropriately sized guidewire. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect, and/or consequential damages of any kind and however caused arising from the sale or use of the product. the dynanail mini fusion system in extended lengths was designed for use in midfoot reconstruction procedures and features patented and proven superelastic internal nitinol compressive element technology now miniaturized to accommodate smaller bone anatomy 2,3unlike traditional beaming devices that lose compression within 1 mm of bone Background DJO Wrist and Finger Undersleeve Instruction Manual, MAYTAG 4.5 Cu. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. Store the DynaNail Deployment Frame and Ancillary Surgical Instruments in the DynaNail Instrument Caddy. DALLAS--(BUSINESS WIRE)--DJO, a subsidiary of Colfax Corporation (NYSE: CFX) and a leading global provider of medical technologies to get and keep people moving, today announced the launch of the MedShape DynaNail Hybrid Fusion System. The patient should be advised that noncompliance with postoperative instructions could lead to loosening, bending or breakage of the implant, requiring revision surgery to remove the device. Unlike traditional screws that lose compression post-operatively, the DynaNail Hybrid maintains compression up to 5 mm of bone settling or resorption depending on implant length.1, The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures, medial column fusion procedu. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Read More About This Manual & Download PDF: step2bed mini Assembly Instructions www.step2health.com www.facebook.com/step2bed 1. Tibiotalocalcaneal Arthrodesis with Intramedullary Nails - Mechanobiological Background and Evolution of Compressive Technology. The physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions: It is the responsibility of the surgeon to provide the patient with appropriate information prior to surgery. The DynaNail Mini Deployment Frame and Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. Other sterilization cycles may also be suitable, but the individuals or hospitals are advised to validate other methods for use with MedShape products. The DynaNail TTC Fusion System is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. The DynaNail Mini Hybrid is substantially equivalent in Intended Use, design, function, material, diameter and length to the following predicate devices: DynaNail Mini, Orthopedic Nail, K182677. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. The surgeon must make the final decision regarding implant removal. The quality of water should be carefully considered for use in cleaning reusable evinces. Some of the products advertised on this website may not be licensed in accordance with Canadian law. Refer to Table A for manual cleaning steps. *Alternative Technique*. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiological examination) is established. and sterilized prior to surgical use. Irritational injury of soft tissues, including impingement syndrome. Post-traumatic or primary arthrosis involving both ankle and subtalar joints. Post-traumatic and degenerative arthritis. The DynaNail Mini Fusion System is used for fracture fixation . Use flowing water and disposable wipes to remove excess soil. To view the purposes they believe they have legitimate interest for, or to object to this data processing use the vendor list link below. Never attempt to reuse the devices, even though they may appear undamaged. The use of supplemental bone graft is at the discretion of the treating surgeon but must be documented. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. If the sterile packaging is found to be damaged or open, do not use the device or attempt to resterilize. An item which poses unacceptable risks to the patient, medical staff or other persons within the MR environment. Prior to surgery, instruments should be fully inspected for any evidence of damage or corrosion. Ensure that cutting / sharp edges are protected. The use of this product is intended to be limited to persons trained in the procedure and knowledgeable of the inherent risks. Rinse instruments following exposure to hydrogen peroxide. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the Fusion Nail, End Cap, and/or Screws following implantation, if required. 04882; UDI: M97026000500060: Recalling Firm/ Manufacturer: Medshape, INC. 1575 Northside Dr Nw Ste 440 Atlanta GA 30318-4211: For Additional Information Contact: Jason Whyte 678-235-3314 Manufacturer Reason for Recall Comment * document.getElementById("comment").setAttribute("id","aca1f0c90a5e9c87e2f6c09ac786d880");document.getElementById("afe6277d1c").setAttribute("id","comment"); Save my name, email, and website in this browser for the next time I comment. Prevaccuum/Pulsating Vacuum/FlashAutoclave, SO 15223-1 Medical Devices Symbols To Be Used with Medical Device Labels, Labeling, and Information To Be Supplied. active compression, PLUS manual intraoperative compression. Follow Universal Precautions for handling and transporting contaminated instruments to the designated cleaning area. Keep instruments moist after use to prevent soil from drying on them. Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. Here gain compression , normalized to small signal gain , is plotted against input power. Use care in handling and storage of the instruments. To minimize possible interference risks during medical imaging such as magnetic resonance imaging (MRI), advise the patient to mention that he/she was implanted with a metallic device. Connect corresponding. Patients with foreign body sensitivity is suspected, or documented metal allergy or intolerance. . The Deployment Frame, Guide Sleeve, and appropriate Drill Guide may be used to target all drills/screws except for the most proximal hole on the 26 cm and 30 cm length DynaNail implants. Always follow the sterilizer manufacturers recommendations. Patients with an active local or systemic infection. The physician should always have a full inventory of sterile DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers on hand at the time of surgery to ensure availability of the optimum size for the patient. The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. The DynaNail Deployment Frame and the Ancillary Surgical Instruments are provided NON-STERILE. Limited LiabilityThe DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are guaranteed for materials, function, and workmanship for a single patient use.The Ancillary Surgical Instruments are guaranteed to be free from defects due to materials or workmanship and have a one (1) year limited warranty.DJO shall not be liable, expressly or implied for any damage which might arise or be caused, whether by the customer or by any of the users of the product, as a result of: THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON DJOS PART. Just connect the Nail Guide to the Mini Targeting Frame and implant! Visually inspect all instruments to ensure that all blood, saline, and traces of tissue are removed, and instruments are visibly clean.Refer to Table A for further cleaning instructions. The DynaNail Mini Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. The DynaNail Mini represents the latest innovation in the DynaNail product line to feature an internal NiTiNOL Compressive Element. Do not rely upon automated cleaning using a washer/disinfector alone as this may not be effective for devices and instruments with cannulations, blind holes, mated surfaces and other complex features. To learn more about what we collect and how we use that information, or to change your privacy settings see our Privacy Policy. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. Remove all plastic, imperii Mini SPY Earpiece INSTRUCTIONS To connect the device via Bluetooth, long press the ON button (1) for, Nespresso Essenza Mini Manual - Optimized PDF Nespresso Essenza Mini Manual - Original PDF For Nespresso- Recipe, Hunting Instruction Manual - Optimized PDF Hunting Instruction Manual - Original PDF, Your email address will not be published. Failure to do so may result in loosening, bending, cracking or fracture of the device or injury to the patients bone or both. The DynaNail Helix Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. End of life is normally determined by wear and damage due to use. 02Issued 03/2021. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. imperii Mini SPY Earpiece Instruction Manual, Novlistve 880788509328 Wireless Earbuds Bluetooth Headphones, NEC NP-M322W Smart Digital Projector Users Manual, SOLAX 0148083 BMS Parallel Box-II for Parallel Connection of 2 Battery Strings Installation Guide, LEDVANCE G11151664 Emergency Conversion Box Instruction Manual, havit SMART26 26 Keys Bluetooth Number Pad User Manual, EMERIL LAGASSE FAFO-001 French Door Air Fryer 360 Owners Manual, 10Gtek WD-4503AC Wireless Adapter Installation Guide, THETFORD SANICON Turbo 700 Owners Manual, FLOOR POLICE 15262-6 Cordless Electric Spinning Microfiber Flat Mop Instruction Manual. All cleaning and sterilization of the DynaNail. Systemic or metabolic disorders or replacement. When evaluating patients for implantation using the DynaNail Mini Fusion System, always consider the patients weight, occupation, activity level and the presence of any degenerative disease. The DynaNail TTC Fusion System includes nickel and titanium materials. Gravity displacement sterilization is not recommended due to extended cycle times. Apply external manual compression by rotating the Compress Knob clockwise on the Deployment Frame. Refer to the Instrument Tray and/or illustration in DJO's Surgical Technique Guide for the completely . End of life is normally determined by wear and damage due to use. Instruments should be cleaned as soon as reasonably practical after use, according to the healthcare facilitys infection control and hazardous waste management procedures. In Sets: Load MedShape Surgical Instruments into the appropriateinstrument trays. Damage to the implants surface finish may result in loss of proper mechanical function of the device. The DynaNail Screws are manufactured from titanium alloy (Ti 6Al-4V ELI) and are available in a range of lengths. Patients should be cautioned against unassisted activity that requires walking or lifting.Any patient who cannot properly utilize weight support devices may be particularly at risk during postoperative rehabilitation. The patient should not have unrealistic expectations regarding the results that the surgery and implant may provide. It is the responsibility of the user to ensure that the sterilization process is actually performed using qualified equipment, materials, and personnel such that the recommended parameters are achieved. Each patient should understand that the implant is manufactured from titanium alloys which may cause possible reactions and complications, including those listed herein. Do not modify the implant. The DynaNail TTC Fusion Nail is manufactured from nitinol and titanium alloy (Ti 6Al-4V ELI) and is available in multiple diameters and lengths. Where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantation. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page. 3. Home DYNANAIL DYNANAIL TTC Fusion System Instructions. Read this file to learn about the surgical technique guide of this innovative product from MedShape. Use in any manner or medical procedure other than those for which it is designed; and any special, indirect and/or consequential damages of any kind and however caused arising from the sale or use of the product. Return ConditionsIn the event the device must be returned for any reason, return the product in the original packaging. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures and other large bone fusion procedures. No reassembly is necessary as the instruments remain in their fully disassembled form during cleaning and sterilization. Loss of fixation in bone attribute to nonunion, osteoporosis and/or markedly unstable comminuted fractures. Global J of Orthopedics Research, 2019. Contact DJO customer service for replacements. The surgeon is responsible for patient selection. Hybrid screw/nail design of the DynaNail Hybrid combines sustained dynamic compressive power with easy, intuitive insertion. on MEDSHAPE DynaNail Mini Fusion System Instruction Manual, MEDSHAPE DynaNail Mini Fusion System Instruction Manual, 14. For manual washing, MedShape recommends using cold demineralized or distilled water along with a neutral pH (7-8.5) enzymatic detergent. The quality of water should be carefully considered for use in cleaning reusable devices. Skeletally immature patients where the implant would cross open epiphyseal plates. Keep instruments moist after use to prevent soil from drying on them. Instruments should be cleaned as soon as reasonably practical after use, according to the health care facilitys infection control and hazardous waste management procedures. All instruments should be thoroughly cleaned. central supply wrap (CSR), paper/plastic pouches, rigid containers, etc.) Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome. Manual cleaning should be done while the instrument is immersed. Your email address will not be published. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. We and our partners use cookies to Store and/or access information on a device.We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development.An example of data being processed may be a unique identifier stored in a cookie. These guidelines are not intended for MedShape implants or single-use disposable instruments only for reusableinstruments that are supplied non-sterile but are intended to be used in a sterile state. Store the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments in the DynaNail Mini Instrument Caddy. Single: A standard packaging material may be used. Loosening, bending, cracking or fracture of the implant components. Do not stack the DynaNail Mini Instrument Caddies during sterilization. This newest version comes in longer lengths (110-140 mm) which offer better stability and post-operative NiTiNOl compression across the midfoot bone anatomy, according to the company. Containment devices can be stacked forstorage. All instruments should be thoroughly cleaned. Use of the implant or system components for these purposes may result in patient injury. Call your DJO sales representative for a replacement. Patients with an active soft tissue infection or osteomyelitis of foot and ankle. 2 deskripsi perangkat. All cleaning should be performed in a manner designed to minimize exposure to bloodborne pathogens. Distal transverse screw provides additional stability and prevents device migration. The DynaNail Mini Fusion System is designed for use in subtalar fusion and medial column fusion as well as the fusion of other large bones in the foot and ankle. Failure to immobilize the ankle during healing may result in bending and/or breakage of the device and/or failed fusion. Note: If you have questions concerning the disassembly of the instruments, contact the MedShape Customer Service or your local MedShape sales representative. Internal NiTiNOL element offers between 2 - 5 mm of When sterilizing multiple sets, ensure that the manufacturers maximum load is not exceeded. Place small parts in baskets to prevent dislodging. DEVICE DESCRIPTION The DynaNail Mini Fusion System consists of the following components: Fusion Nail DynaNail Mini Fusion Nail DynaNail Mini Hybrid Fusion Nail End Cap Screws The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. The physician should always have a full inventory of sterile Fusion Nails and Screw sizes on hand at the time of surgery to ensure availability of the optimum size for the patient. Return Conditions:In the event the device must be returned for any reason, return the product in the original packaging. Always handle the DynaNail TTC Fusion Nail carefully. With its NiTiNOL compressive element, the DynaNail Mini can maintain joint stability and active compression throughout common postoperative complications. Drug and/or alcohol and/or smoke addiction and/or abuse. Follow the manufacturers instructions for mixing, preparing, and using such detergents. Patients who are obese or noncompliant, as well as patients who could be predisposed to delayed union or nonunion, must have auxiliary support. It has not been tested for heating, migration, or image artifact in the MR environment. and sterilized prior to surgical use. : http://www.medshape.com/patents.htmlMK-10062 Rev. If any of the components are damaged during attempted placement, additional sterile components of the same size should be available. 5 potensi efek samping. Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. Designed for use in subtalar fusion procedures, the DynaNail Hybrid contains an Superelastic Internal NiTiNOL Element that maintains active, dynamic compression in response to bone settling or resorption. Do not add other instruments to the DynaNail Instrument Caddy that are not part of the standard configuration supplied by MedShape. Limited Liability:The DynaNail TTC Fusion Nail, DynaNail End Cap, and the DynaNail Screws are guaranteed for materials, function, and workmanship for single patient use. Handling of the DynaNail Mini Deployment Frame and the Ancillary Surgical Instruments must be performed in accordance with aseptic handling practices to maintain sterility following sterilization by the healthcare facility. Do not stack the DynaNail Instrument Caddies during sterilization. To minimize possible interference risks during medical imaging such as magnetic resonance imaging (MRI), advise the patient to mention that he/she was implanted with a metallic device. Resterilization may result in loss of proper mechanical function of the device and could result in patient injury.Carefully inspect product packaging and all device components for damage or defects prior to use. The Ancillary Surgical Instruments must be placed in the designated location within the DynaNail Helix Instrument Tray. . Global J Orthopedic Research, 2019. Careful preoperative planning must be conducted based on radiographic findings. Similar to its larger predecessor, the DynaNail TTC Fusion System, it features MedShape's patented internal superelastic NiTiNOL technology that provides strong joint stability due . Patients with an active soft tissue infection or osteomyelitis of foot and ankle. Contact Customer Service or an authorized DJO representative to receive a return authorization number prior to return shipment. Rigid sterilization container that complies with ANSI/AAMI ST46. The DynaNail TTC Fusion System is the ONLY fusion approach that offers the compression performance of an external fixator inside an intramedullary nail. The DynaNail TTC Fusion System is designed for use in tibiotalocalcaneal (TTC) fusion, or hindfoot fusion, procedures to address degenerative conditions, correct joint deformities and revise failed total ankle replacements or arthrodesis non-unions. Systemic or metabolic disorders or replacement. The DynaNail Mini Fusion Components are provided sterile for single use only. . THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED, AND/OR STATUTORY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS, AND/OR SUITABILITY FOR A PARTICULAR PURPOSE, AND OF ALL OTHER OBLIGATIONS OR LIABILITIES ON MEDSHAPES PART. The consent submitted will only be used for data processing originating from this website. In the case of very small dimension cannulations, a wire can be used to ensure that foreign material has been removed from the cannulation. The contents of this website do not constitute medical, legal, or any other type of professional advice. Refer to Table A for further cleaning instructions. According to ANSI/AAMI standard ST79:2010. the accepted standard for the degree of cleanliness is visibly clean. Read all package insert warnings, precautions, and instructions. The healthcare facility is responsible for in-house procedures for the reassembly, inspection, and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. Sensitivity, allergies, or other reaction to the device material. Potential adverse effects resulting from the use of the DynaNail Helix Fixation System include, but are not limited to, the following: Adverse effects may necessitate reoperation, revision, or removal surgery and/or amputation of the limb. Patients with an obliterated medullary canal or other conditions that tend to retard healing such as blood supply limitations or previous infections. Damage to the implants surface finish may result in loss of proper mechanical function of the device. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture. Store the DynaNail Mini Fusion System Components in a dry place at room temperature (20oC to 25oC). The DynaNail Mini features a. Cannulated portions should be cleaned with a soft-bristled nylon brush, pipe cleaner, or appropriately sized guidewire. Loss of anatomic positioning with nonunion or malunion with rotation or angulation. These specialized instruments are required to correctly perform the implantation procedure and to remove the Fusion Nail and Screws if required, following implantation. For more information visit us at https://www . Once the Fusion Nail, End Cap, and Screws have been removed from the packaging, the device should be either used or discarded. DynaNail Mini was introduced in 2019 with 60-100 mm lengths for use in subtalar fusion procedures. Place all parts on a flat working surface. he patient should be provided with detailed written instructions regarding postoperative care, and the use and limitations of the device.Postoperative care and physical therapy should be structured to prevent loading of the operative extremity until stability is evident. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. The DynaNail Mini Fusion System is intended to facilitate healing but is not designed to support the patients body weight in the presence of a delayed union or nonunion of bone. Les sections de ce cours vous permettrons de tout. When utilizing an automated cleaner follow equipment manufacturers instructions for use, incorporating low foaming. The DynaNail Helix Threaded Bone Fastener and DynaNail Helix Washer are provided sterile for single use only. The patient should be encouraged to report to his/her surgeon any unusual changes to the operated extremity. Repeat the process until no visible debris remains. Demonstrates physiologic or anatomic anomalies. Carefully select the appropriate DynaNail Screw sizes based on the needs of each individual patient. Visually inspect all instruments for damage and wear. Irritational injury of soft tissues, including impingement syndrome. Unwillingness to accept the possibility of multiple surgeries for revision or replacement. Manage Preferences. Following the presoak the instruments should be wiped or scrubbed using a brush, cloth or sponge that does not mar the surface of the instrument. The DynaNail Helix Fixation System consists of the following components: The DynaNail Helix Fixation System is implanted using the Ancillary Surgical Instruments. The DynaNail Mini Fusion System is an innovative intramedullary nail system designed for use in subtalar fusion procedures, medial column fusion procedures, and other large bone fusion procedures. The healthcare facility is responsible for in-house procedures for the reassembly, inspection and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. The surgeon is responsible for patient selection. Lacks an understanding that their preoperative capacity may not be fully recovered even after successful implantation. Until firm bony union is achieved, the patient should employ adequate external support and restrict physical activities that would place stress upon the implant or allow movement at the site and delay healing. 11 petunjuk penggunaan. According to the Association for the Study of Internal Fixation principles, compression across a fusion site promotes bone healing and also provides . Failure to do so may result in loosening, bending, cracking or fracture of the device or injury to the patients bone or both. Manual cleaning should be done while the instrument is immersed. Patients with an insufficient plantar pad. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials. Sterrad or hydrogen peroxide-based gas systems have not been validated. The patient should be informed that the life expectancy of the device is unpredictable once implanted and that successful results cannot be guaranteed. Some of our partners may process your data as a part of their legitimate business interest without asking for consent. Therefore, it is important that immobilization of the site is maintained until firm bony union (confirmed by clinical and radiologicalexamination) is established. Always handle the DynaNail Mini Fusion System carefully. The carbon-fiber PEEK frame also features a robust, universal one-arm design allows for reliable drilling and screw placement. Never attempt to reuse. The appearance of bubbles confirms the presence of protein and the instrument should be re- cleaned. Cutting edges should be free of nicks and present a continuous edge. If bubbles were present or instruments were not deemed visibly clean, steps 1-8 of the manual cleaning process should be repeated. The Ancillary Surgical Instruments should not be reused if visible deterioration such as corrosion or damage resulting from use or handling is evident. If sensitivity to nickel or titanium is suspected, appropriate testing should be conducted prior to use. Packaged and sterilized instruments should be stored in an area that provides protection from dust moisture, insects, vermin, and extremes of temperature and humidity. It is the physicians responsibility to determine the correct size of the Fusion Nail and Screws to be implanted. In the US, users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been clearly the US FDA for the selected sterilization cycle specifications (132C, 4 minutes). After implanting DynaNail, the Compressive Element is stretched 6 mm and fixed in the stretched position with two screws (one posterior-anterior and one lateral-medial) in the calcaneus allowing. Store the Ancillary Surgical Instruments in the DynaNail Helix Instrument Tray. Use care in handling and storage of the instruments. Repeated reprocessing has minimal effect on the devices. Use only DynaNail Helix Fixation System components. Please remove any damaged device or instrument from use and call your MedShape sales representative for a replacement. Failure to do so may result in loosening, bending, cracking, or fracture of the device or injury to the patients bone or both. Your email address will not be published. Alternate fixation methods should also be available for use in the event that the DynaNail Mini Fusion System cannot be successfully implanted. Neuromuscular disease and severe deformity. The DynaNail Mini is provided with the NiTiNOL Element pre-stretched and pre-loaded on a disposable Nail Guide. Never attempt to reuse. If you would like to change your settings or withdraw consent at any time, the link to do so is in our privacy policy accessible from our home page. The surface of the implant must always be protected from damage during handling. Consult Instructions For Use. Rinse instruments following exposure to hydrogen peroxide. Tissue reactions including macrophage and foreign body reactions adjacent to implants. Manage SettingsContinue with Recommended Cookies, MEDSHAPE DynaNail Mini Fusion System Instruction Manual 1. instruments should be fully inspected for any evidence of damage or corrosion. Patients with conditions that restrict his or her ability or willingness to follow postoperative instructions during the healing process. The MedShape DynaNail Mini will then be inserted according to the manufacturer's technique. First used clinically under a limited market release in 2019, the DynaNail Mini has been implanted by over 50 orthopedic surgeons in over 50 hospitals across the United States.. Cutting edges should be free of nicks and present a continuous edge. The healthcare facility is responsible for in-house procedures for the reassembly, inspection and packaging of the instruments after they are thoroughly cleaned in a manner that will ensure steam sterilant penetration and adequate drying. The DynaNail Helix Fixation System has not been evaluated for safety and compatibility in the MR environment. Rigid sterilization container that complies with ANSI/AAMI ST46. Required fields are marked *. Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training and experience. Misuse, mishandling and/or improper operation. The DynaNail TTC Fusion System should only be used by those physicians who have been trained in the appropriate, specialized procedures. Visually inspect all instruments for any remaining debris prior to sterilization. It is the responsibility of the user to ensure that the sterilization process is actually performed using qualified equipment, materials, and personnel such that the recommended parameters are achieved. It is critical that the appropriate process parameters be validated for each healthcare facilitys sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes to substantiate the process and its reliability and reproducibility. The DynaNail TTC Fusion Nail, DynaNail End Cap, and DynaNail Screws are provided sterile for single use only. Contaminated instruments should be transported to the area for cleaning in a way that avoids contamination of personnel and hospital. 7. Demonstrated psychological instability, inappropriate motivation, or attitude. DynaNail TTC Fusion System is designed for use in tibiotalocalcaneal (TTC) fusion, or hindfoot fusion, procedures to address degenerative conditions, correct joint deformities and revise failed total ankle replacements or arthrodesis non-unions. The company first released the DynaNail TTC Fusion. The Fusion Nail, End Cap, and Screws are supplied sterile for single use only. Reusable instruments should be placed in suitable packaging for the sterilization process (i.e. Refer to the Instrument Tray and/or illustration in MedShapes Surgical Technique Guide for the completely disassembled components. Patients with an insufficient quantity or quality of bone to permit fusion of the joints or stabilization of the arthrodesis. The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be best for each individual patient. DO NOT ATTEMPT TO RESTERILIZE. Manage SettingsContinue with Recommended Cookies, Home MEDSHAPE MEDSHAPE DynaNail Mini Fusion System Instruction Manual, The DynaNail Mini Fusion System consists of the following components: Fusion Nail. To minimize possible interference risks during medical imaging such as magnetic resonance imaging (MRI), advise the patient to mention that he/she was implanted with a metallic device. Nucleus visually depicts the main surgical steps involved while . The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. Patients with severe longitudinal deformity. Do not add other instruments to the DynaNail Helix Instrument Tray that are not part of the standard configuration supplied by DJO. Ancillary Surgical Instruments are required to complete the implant procedure and to remove the DynaNail Helix Threaded Bone Fasteners and DynaNail Helix Washers following implantation, if required.Intraoperative fluoroscopy (C-Arm) should be available and utilized as required to confirm correct positioning of the DynaNail Helix Fixation System implants. The initial clinical outcomes with the DynaNail Mini Fusion System for subtalar fusion procedures were reported today by MedShape. 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