BIOMET

2.4MM HITCH(TM)

BIOMET Instruments and Cases Instructions for Use

3 Pages

ENGLISH 5401000301 EN Rev. B  IFU FOR INSTRUMENTS AND CASES UKBEN54010003011  FOR THE ATTENTION OF THE OPERATING SURGEON, HEALTHCARE PROFESSIONALS, CENTRAL STERILE SERVICES DEPARTMENT (CSSD) PERSONNEL For additional information please see: http://labeling.zimmerbiomet.com/ SURGICAL INSTRUMENTS For detailed information concerning the identification of the product (such as device description, catalogue number and associated system), please refer to the labelling on the package and/or marking on the device. Important information for the operating surgeon Before using an instrument placed on the market by Zimmer Biomet, the operating surgeon, healthcare professionals and central sterile services department (CSSD) personnel should study carefully the following recommendations, warnings and instructions, as well as the available instrument-specific information (e.g. product literature, surgical technique, Reusable Instrument Lifespan Manual 1219 and Instrument Assembly and Disassembly Manual 1258 or product-specific Assembly and Disassembly Manual where applicable) from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com. Zimmer Biomet is not liable for complications that may arise from use of the instruments in circumstances outside the control of Zimmer or Biomet including, but not limited to, deviations from the instruments’ indicated uses or surgical technique. DESCRIPTION These instructions for use (IFU) provide information on the care, cleaning, disinfection, maintenance and sterilization of manual surgical instruments. Biomet surgical instruments and instrument cases are generally composed of aluminium, stainless steel, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow for sterilization of the contents to occur in a steam sterilizer utilizing a cycle that has been validated by the user for the equipment and procedures employed at the user’s facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap or rigid container to maintain sterility. INTENDED PURPOSE Biomet surgical instruments are designed for Biomet® implant systems and intended to be used by orthopaedic surgeons to facilitate the implantation or explantation of specific implants described in the product-specific surgical technique or surgical approach. The use of the identified instrumentation in accordance with its applicable surgical technique and IFU is essential to achieve the intended placement of the implant as described in the relevant surgical technique. The use of incompatible instruments (e.g. from another system) may lead to unpredictable short- and long- term clinical consequences. The incorrect use of the subject instrumentation may also lead to short- and long term clinical consequences. Sterilization case components are intended to facilitate the organization, identification, storage, transportation, cleaning, and sterilization reprocessing of instruments and provisionals. General surgical instruments are available to facilitate surgical procedures unrelated to a specific implant system or related to a surgical approach. The patient target population can be found in the specific implant instructions for use.  Change Control No: 232263 Revision B Date: August 2021 © Biomet  BIOMET UK LIMITED WATERTON INDUSTRIAL ESTATE BRIDGEND, CF31 3XA UNITED KINGDOM TEL: + 44 (0) 1656655221 FAX: + 44 (0) 1656645454 www.zimmerbiomet.com For individual CE mark of instruments, refer to the product label INTENDED USERS Operating surgeon, healthcare professionals and central sterile services department (CSSD) personnel. Table 1. Materials Scientific notation CF-PEEK PEEK SST or Stainless Steel Co-Cr-Mo PPSU Ti-6Al-4V POM/C Silicone PPHS PTFE  Material Description Carbon fibre – Poly ether ether ketone Polyether ether ketone Stainless steel Cobalt-chromium-molybdenum alloy Polyphenylsulfone Titanium-6aluminium-4vanadium alloy Polyacetal copolymer Silicone Heat-stabilized polypropylene Teflon / Polytetrafluoroethylene  INDICATIONS, CONTRAINDICATIONS AND PATIENT SELECTION FACTORS Refer to the implant-specific IFU for information on the intended purpose, indications and contraindications of the implant. WARNINGS, PRECAUTIONS AND RESIDUAL RISKS Correct use and handling of instruments is extremely important. Do not modify instruments. Do not notch or bend instruments. Notches, scratches or other damage and/or wear in the instrument occurring during surgery may contribute to breakage and potential adverse effects on users or patients. 1. Do not reshape or bend instruments in any way. Do not use an instrument that has become bent out of its original shape as this will affect the performance of the instrument. See also the Reusable Instrument Lifespan Manual 1219 for determining end of life by wear and damage due to use. Bent instruments should be disposed of. 2. The Surgeon is to be thoroughly familiar with the implants, instruments, surgical technique and surgical procedure prior to performing surgery. For Instruments intended to be connected to a power tool refer to the applicable surgical technique for information on the connection to the power tool. Visit the company website (see front page) or contact your local Zimmer Biomet representative to obtain the latest surgical technique. 3. Surgical instruments should only be used for their intended purpose. 4. Only devices manufactured and/or distributed by Biomet should be included in Biomet instrument trays and cases. These validated reprocessing instructions are not applicable to Biomet trays and cases that include devices that are not manufactured and/or distributed by Biomet. 5. The use of instruments and provisionals with devices not designed to be used with during the surgical procedure can result in inaccurate fit, in correct sizing, excessive wear and device failure. Refer to the product-specific surgical technique or associated surgical approach for accepted combinations. General instruments such as hammer can be used safely across systems and do not raise compatibility concerns due to their generic intended use or function. 6. Intraoperative fracture or breaking of instruments has been reported for instruments. 7. Biomet recommends that all instruments be regularly inspected for wear and disfigurement prior to use See also the reusable instruments Lifespan Manual 1219 for determining end of life by wear and damage due to use. All trial, packaging, and instrument components must be removed prior to closing the surgical site. Do not implant. 8. Surgical instruments are subject to wear with normal usage. Instruments with cutting functions or points may become dull with normal use and no longer perform as intended. Inspect prior to use to verify the cutting ability and sharpness of edges. See also the reusable instruments Lifespan Manual 1219 for determining end of life by wear and damage due to use. 9. The use of instruments overtime may lead to wear and particle release, which could have clinical implications and potentially lead to adverse events. 10. Instruments that have experienced extensive use or excessive force are susceptible to fracture.  Page 1 of 3  11. Polymer provisionals may show eventual surface degradation from the heat and chemicals used in hospital cleaning and steam sterilization. Replace the provisional when degradation makes cleaning difficult or if the surface becomes chalky. 12. Universal precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges. 13. The patient is to be warned by his/her physician of all surgical risks and made aware of possible adverse effects in advance of surgery. The patient should also be informed about any product related risks identified in the relevant instrumentation and implant system IFU. 14. Unless otherwise indicated, instruments are NOT STERILE and must be thoroughly cleaned and sterilized prior to use as per instructions provided in this IFU. 15. Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean may not be effectively sterilized. See also Instruments Assembly Disassembly Manual 1258 or product-specific Assembly Disassembly Manual where applicable. 16. Automated cleaning using a washer/disinfector alone may not be effective for complex instruments with lumens, cannulations, blind holes, mated surfaces and other features that may need to be disassembled before cleaning. Therefore, manual cleaning may also be required. See also Instruments Assembly Disassembly Manual 1258 or product-specific Assembly Disassembly Manual, where applicable, for disassembly instructions prior to cleaning/sterilization. 17. Do not clean soiled instruments while in polymer or metal trays. 18. Metal instruments or fragments can be located by radiography or fluoroscopy. Non-metal instruments or fragments may not be located by radiography or fluoroscopy, and should be accounted for at the end of the surgical procedure. 19. Any decision not to remove broken or fragmented instruments, or a broken drill or drill fragments, is at the surgeon’s discretion and must take into account the associated risk. 20. If corrosive media such as silver nitrate, iodine preparations, albotyl and mercury compounds are used during the operation, all residues of these substances must be removed from the instruments immediately. 21. The presence of potential carcinogenic, mutagenic or toxic to reproduction (CMR) substances and/or substances with endocrine disrupting properties defined as CMR 1B substances in a concentration above 0.1% weight by weight in the product is indicated by the symbol on the product label followed by the respective substance identifier. • Cobalt; CAS No.: 7440-48-4 For further details, please review: https://echa.europa.eu/home. There are isolated case studies in which patients were diagnosed with cancer while having a device manufactured from cobalt alloys in place that hypothesized at a causal nexus between the device and the diagnosis. However, current scientific evidence supports that the incidence of developing cancer or suffering from adverse reproductive effects for patients with a device manufactured from cobalt alloys or stainless steel alloys containing cobalt is comparable to the respective incidence for the general population. 22. Patients/users hypersensitive to any of the instruments material (e.g. cobalt, chromium, nickel) may suffer an allergic reaction. The duration of the contact between instruments and patient/users is transient. If you have any concerns for potential allergic reactions, please contact your Zimmer Biomet sales representative. RESPONSIBILITIES OF THE USER A. Cleaning/Disinfection The health care facility is responsible for ensuring that conditions essential to safe handling and cleaning/disinfection can be achieved. ANSI/AAMI/ ISO 17664 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices and ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provide guidelines for design and personnel considerations, immediate handling of contaminated items and transportation, decontamination processes, servicing, repair, and process performance. Universal Precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Care should be taken to avoid penetrating or cutting injuries. Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices and equipment. PPE includes gown, mask, goggles or face shield, gloves and shoe covers. Cleaning agents with low foaming surfactants should be used during manual cleaning procedures to ensure that instruments are visible in the cleaning solution. Manual scrubbing with brushes should always be performed with the instrument below the surface of the cleaning solution to prevent generation of aerosols and splashing, which may spread contaminants. Cleaning agents must be completely rinsed from device surfaces to prevent accumulation of detergent residue. See Assembly and Disassembly Manual 1258 or product-specific Assembly and Disassembly Manual, where applicable, for detailed guidelines related to instrument assembly and disassembly, available from your Zimmer Biomet sales representative or at http://labeling.zimmerbiomet.com.
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