Euloc Fixation System Instructions for Use

Euloc Fixation System - Instructions For Use English IFU-P135-EN-20200930 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, the recommended surgical technique and detailed instructions for cleaning, sterilization and resterilization can be downloaded in PDF format from the Swemac website http://download.swemac.com/Euloc-Fixation-System. Printed documentation can be provided free of charge upon request. Delivery time is maximum 7 days. INTENDED USE: The Euloc Fixation System is designed for the treatment of distal radius and ulna fractures. The implants are single use devices made from implantable stainless steel (ISO 5832-1) and intended for temporary stabilization of radius and/or ulna bone segments or fragments until bone healing and consolidation has been achieved. The device is for professional use only. Description: The Euloc Fixation System consists of anatomically shaped nails and screws available in different lengths. The surgeon must select the most appropriate implants to achieve firm seating and adequate fixation. The system includes specific instruments for the procedure. Indications: • Dorsally displaced bending fractures on the distal part of the radial bone. • Dorsally/radially displaced bending fractures with or without dorsal comminution on the distal part of the radial bone. • Displaced distal ulna fractures. Euloc Fixation System can also be used in combination with a volar plate or external fixation for the following indications: • Instability of the volar cortex. • Volar displacement. • Volar cortical bone comminution. • Severe shortening. • Intra articular comminution (displaced). 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. • Obesity. An obese patient can produce loads on the implant that can lead to device/treatment failure. • Other physical, mental, medical or surgical conditions that would preclude the potential benefit of surgery. 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. WARNINGS: • Do not use the device without reading the surgical technique brochure, which has been provided to the user separately. • The device must only be used by a professional surgeon who is thoroughly familiar with the 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. • Selecting the correct application for each fracture is extremely important to minimize the risk of failed osteosynthesis or breakage of the device and/or bone. It is important that the surgeon applies the device in accordance with the documented surgical technique.

Euloc Fixation 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. • Handle instruments with care. 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 systems. • Percutaneous placement of the nails is not recommended as this will increase the risk of impingement and damage of nerves and tendons. • Be careful not to penetrate the distal radial ulnar joint with the drill or a screw (critical for both radius and ulna). 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. 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. Serious incidents shall be reported to Swemac and the Competent Authority. 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 screws shall be sterilized and re-sterilized by using a validated sterilization process in accordance with ISO 17665. Re-sterilization of the Euloc nails is not permitted due to the risk of bending. Sterile packaging shall be done in accordance to ISO 11607-1. 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

Consult instruction for use download.swemac.com

Do not re-sterilize

Caution

Non-sterile 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: 2020-09-30