Motec Wrist Arthrodesis System Instructions for Use

Motec Wrist Arthrodesis System - Instructions For Use English IFU-P145-EN-20200316 Swemac Innovation AB Cobolgatan 1 SE-583 35 Linköping, Sweden Phone: +46 13374030 E-mail: [email protected] http://www.swemac.com

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FURTHER INFORMATION: This Instruction For Use leaflet is only provided in English. Other languages of this leaflet and the recommended surgical technique as well as detailed instructions for cleaning, sterilization and re-sterilization can be downloaded in PDF format from the Swemac website http://www.swemac.com/ifu/IFU-0145/. Printed documentation can be provided free of charge upon request. Delivery time is maximum 7 days. INTENDED USE: The Motec Wrist Joint Arthrodesis implants are intended to be used as salvage procedures for the Motec Wrist Joint Prosthesis. The system provides salvage options that limit unnecessary implant removal by taking advantage of pre-existing stable and osseointegrated implants from the Motec Wrist Joint Prosthesis. This preserves the bone available for arthrodesis by minimizing bone loss which would otherwise occur during removal of well-fixed implants. The intramedullary system has been developed to reduce soft tissue irritation from hardware and the associated need for secondary implant removal. Description: The Motec Wrist Arthrodesis System is suitable in several cases and has three different options available depending on the patient and implant situation. In cases where both the radius and metacarpal components from the Motec Wrist Joint Prosthesis are stable, there are two possible alternatives; the Double Taper, used as a link between the osseointegrated implants, and the Metacarpal Taper-Radius Connector solution; the Metacarpal Taper is attached distally and the Radius Connector is attached proximally. If the metacarpal component is loose, an intramedullary nail can be used together with the Radius Connector. The Metacarpal Nail is placed inside the metacarpal bone and fixed dorsally by cortical screws. Depending on which solution that is chosen, the wrist can be fused in 0°, 15° or 30° (in relation to the fixed radius component). All implant components are manufactured in blasted titanium alloy (Ti6Al4V). The device is for professional use only. Indications: • Conversion from Motec Wrist Prosthesis System. Contraindications: The physician’s education, training and professional judgment must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include: • Any active or suspected latent infection, sepsis or marked local inflammation in or around the surgical area. • Material sensitivity, documented or suspected. • Physical interference with other implants during implantation or use. • Compromised vascularity, inadequate skin or neurovascular status. • Compromised bone stock that cannot provide adequate support and/or fixation of the device due to disease, infection or prior implantation. • Patients who are unwilling or incapable of following post-operative care instructions. • Other physical, medical or surgical conditions that would preclude the potential benefit of surgery. • Previous open fractures or infections in the joint. COMPATIBILITY: The components included in this system have not been tested for safety, heating, or migration in an MRI environment. Similar products have been tested and evaluated in terms of how they may be safely used using MRI equipment. Prior to an MRI scan, a patient with a Swemac implant must always disclose the specific implant information to their physician. For details see Swemac MRI Statement. The device is compatible with Swemac Motec Wrist Prosthesis System and the instruments from both the Arthrodesis- and the Prosthesis instrument tray are needed for surgery. WARNINGS: • Do not use the device without reading the surgical manual, which has been provided to the user separately. • The device must only be used by a professional surgeon who is thoroughly familiar with indications and contraindications, the implant, the methods of application, instruments, and the recommended surgical technique of the device. • The implant can be available in different sizes and versions. It is important to select the appropriate combination of implant components and sizes taking into consideration the length, body weight, anatomy and functional demands of the patient. Implants which consist of several components must only be used in the described combination (see surgical manual). • Improper insertion of the device during implantation can increase the risk of loosening or migration. • Improper positioning of the device may lead to clinical failure. • Do not reuse the implants, since previous stresses may have created imperfections, which can lead to a device failure. • Do not touch sharp edges of instruments or implants. • If either the product or package seems damaged, contaminated or if sterility is questioned for any reason, the product shall not be used. • Do not re-use single use guide wires. Single use guide wires may be damaged or bent during surgical procedures. If a single use guide wire is re-used it may become lodged in a drill or reamer and unintentionally advanced into the body. • Drills and reamers with measuring function must not be re-sharpened. • Insufficient quantity or quality of bone/soft tissue may increase the risk of loosening or migration. • Do not re-sterilize the sterile packed implants because this could lead to surface damages.

Motec Wrist Arthrodesis System

PRECAUTIONS: • Ensure that all components needed for the operation are available in the surgical theatre. • Inspection is recommended prior to surgery to determine if implants have been contaminated or damaged during transport or storage. • Instruments should be examined for wear or damage prior to surgery. • Avoid surface damage to the implant and discard all damaged or mishandled implants. • After the procedure check the proper positioning of all implants using an image intensifier. Correct positioning of the implant parts is extremely important for the clinical outcome (see surgical manual). • Do not use components from Swemac in combination with components from other manufacturer’s system. ADVERSE EFFECTS: • Pain, discomfort, abnormal sensations, nerve damage, soft tissue damage, infections, necrosis of bone, bone resorption, necrosis of the tissue or inadequate healing may result from the presence of an implant or due to surgical trauma. • Treatment failure such as fracture or loosening of the implant may occur due to excessive activity, prolonged loading upon the device, incomplete healing, delayed union, non-union or excessive force exerted on the implant during insertion. • Implant migration and/or loosening may occur. • Mal-union may occur. • Shortening of the affected bone/fracture site. • Metal sensitivity, histological or allergic reaction resulting from implantation of a foreign material may occur. • Surgical intervention may be required to treat adverse effects. • Tendinitis or transient neuritis. POSTOPERATIVE CARE INSTRUCTIONS: Postoperative care is extremely important. The physician’s education, training and professional judgment must be relied upon to choose the most appropriate postoperative care. The patient must be cautioned about the use, limitations and possible adverse effects of this implant. The patient must also be warned that the implant and/or treatment might fail if she/he neglects the postoperative care instructions. • The implantation affects the patient’s ability to carry loads and her/his mobility and general living circumstances. For this reason, each patient needs individual instructions on correct behavior after implantation. • The implant is designed as a load sharing device and cannot withstand immediate weight bearing as a load bearing device. • Explain the need to report unusual changes in the implantation area as well as falls or accidents even if the device or the surgical area did not appear to be harmed at the time. STERILITY: The implants are provided sterile or non-sterile. Sterile devices have been exposed to a minimum dose of 25.0 kGy gamma irradiation. If either the implant or the package appears damaged, or if sterility is questioned for any reason, the implant shall not be used. Non-sterile implants must be sterilized by using a validated sterilization process following EN ISO 17665 prior to use. CLEANING AND DISINFECTION: The washer/disinfector used for the automated cleaning process should have proven effectiveness in accordance with ISO 15883. Multi-component instruments should be disassembled before cleaning. For details see Swemac reprocessing instructions. STERILIZATION AND RE-STERILIZATION: The instruments and non-sterile implants shall be sterilized and re-sterilized by using a validated sterilization process in accordance with ISO 17665. Sterile packaging shall be done in accordance to ISO 11607-1. Do not re-sterilize the sterile packed implants because this could lead to surface damages.

The following sterilization parameters are recommended:

134°C for minimum 3 minutes*

132°C for minimum 4 minutes*

* Holding time. These times do not include air removal or penetration. STORAGE INSTRUCTIONS: The package should not be exposed to direct sunlight, ionizing radiation, extreme temperatures or particulate contamination. SYMBOLS USED ON THIS PRODUCT: Sterilized using irradiation

Do not use if package is damaged

Do not reuse

Caution

Non-sterile Consult instruction for use Do not resterilize

download.swemac.com

Keep away from sunlight

RxOnly

CAUTION: Federal law (USA) restricts this device to sale by or on order of a licensed physician or hospital.

Issued: 2020-03-16