Dynaloc Solid System Instructions for Use

Dynaloc Solid System - Instructions For Use English IFU-P150-EN-20220602 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 leaflet is only provided in English. Other languages, any available updates, the recommended surgical techniques, information about wear and detailed instructions for cleaning, sterilisation and re-sterilisation can be downloaded from the Swemac website http://download.swemac.com/Dynaloc. Printed documentation can be provided free of charge upon request and shall be delivered within 7 days. INTENDED USE: The Dynaloc Solid system is an implant system intended for temporary stabilisation of femoral neck fractures in adults until bone consolidation has been achieved. DESCRIPTION: The implants are single use devices, made of implantable Ti6Al4V (ISO 5832-3). The Dynaloc Solid system consists of screws and plates available in different sizes. The system includes specific instruments for the procedure. The device is for professional use only. INDICATION: Femoral neck fractures in adults. CONTRAINDICATIONS: The surgeon’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. • Previously implanted or extracted osteosynthesis implants of the diaphyseal or proximal femur increases the risk of secondary fracture. • Obesity. An obese patient can produce loads on the implant that can lead to device/treatment failure. • Basal fractures of the femoral neck. • Fractures where the inferior screw would not achieve sufficient contact with the inner medial cortex in the distal fragment. • 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. The Dynaloc Solid system is not compatible with implants from other manufacturer’s systems. The Hansson Pinloc Plates are compatible with the Dynaloc Solid Screws. 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 technique brochure). • Improper implantation and/or positioning of the device can increase the risk of loosening or migration and may lead to clinical failure. • Do not re-use 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 must not be re-sharpened. • Insufficient quantity or quality of bone/soft tissue may increase the risk of loosening or migration. • The implant is designed as a load sharing device and cannot withstand immediate weight bearing as a load bearing device. • Selecting the most appropriate fracture fixation method is extremely important. Failure to do so may accelerate clinical failure. Failure to use the correct component to maintain blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or the bone. • It is important to ensure that neither the guide wire or drill penetrate the hip joint. • Do not use the reamer or drill if the cutting edge has been damaged or shows evidence of wear. • Do not place the distal guide wire (for the inferior screw) below the lower edge of the lesser trochanter. • Do not use the Dynaloc Solid system with paediatric hip fractures. • Improper insertion and/or placement of the device during implantation can increase the risk of loosening, migration, chondrolysis, non-union, mal-union, femoral head penetration, cut-out or secondary fracture. • The use of Dynaloc Solid for treatment of high sub-capital fracture without cortical support in the proximal fragment is associated with an increased risk of excessive dynamisation. • The system is not intended for spinal use.

Dynaloc Solid 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. For details see Swemac Inspection Instructions. • 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 technique brochure). • The surgeon must be proficient in fracture reduction. • Ensure that the guide wires and the screws are inserted parallel. Screws which are not parallel might lead to improper function and reduced performance of the implant. 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 surgeon’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. • The patient must be informed about 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. 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. 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. STERILISATION AND RE-STERILISATION: The instruments shall be sterilised and re-sterilised by using a validated steriliation process in accordance with ISO 17665. Sterile packaging shall be done in accordance to EN-ISO 11607-1. Re-sterilisation of a sterile implant is prohibited due to potential negative impact on the safety and performance of the device.

The following sterilisation 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, ionising radiation, extreme temperatures or particulate contamination. SYMBOLS USED ON THIS PRODUCT: Sterilised using irradiation

Do not use if package is damaged

Do not reuse

Consult instruction for use download.swemac.com

Do not re-sterilise

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: 2022-06-02