BIOMET

2.5MM DRILL GUIDE LONG

BIOMET Surgical Instruments and Cases Instructions for Care

3 Pages

ENGLISH  Revision C Date: 2021-11-15 © Biomet  01-50-1539 EN Rev. C  Instructions for the Care, Cleaning, Maintenance, Handling, and Sterilization of Biomet Surgical Instruments and Instrument Cases  BIOMET GSCC B.V. Hazeldonk 6530 4836 LD Breda The Netherlands  Biomet Orthopedics  Biomet Trauma  56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA  56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA  Biomet Sports Medicine  Biomet Biologics  56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA  56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581 USA  1AMEN015015391 ENGLISH  EN  Instructions for the Care, Cleaning, Maintenance, Handling, and Sterilization of Biomet Surgical Instruments and Instrument Cases Before using a product placed on the market by Biomet, the operating surgeon should study carefully the following recommendations, warnings and instructions, as well as the available product-specific information (e.g. product literature, written surgical technique). Biomet is not liable for complications that may arise from use of the device in circumstances outside of Biomet’s control including, but not limited to, product selection and deviations from the device’s indicated uses or surgical technique. DESCRIPTION This instruction manual provides information on the care, cleaning, disinfection, maintenance and sterilization of manual surgical instruments. Biomet individual instruments and instrument cases are generally composed of aluminum, 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 and holders. 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 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. This instruction manual is not applicable to air driven or electrically powered equipment. However, it is applicable to functional attachments (e.g. reamers and drill bits) that are connected to powered equipment for use. Unless otherwise specified, rulers and calipers intended to provide a measuring function are accurate within +/- one-half the smallest division on the scale. INTENDED USE: Instruments and instrument cases are intended to: • facilitate implantation of orthopedic medical devices, or • facilitate preparation and application of bone cement to fix orthopedic medical devices to living bone, or • facilitate point of care processing or application of autologous blood and/or bone marrow component(s) or bone graft handling applications. symbol on the package label. Instruments and instrument cases are medical devices and may be identified with the INTENDED USERS: Surgical instruments are intended to be used by: • Surgeons trained to perform orthopedic surgical procedures • Facility central process staff trained to handle, clean, and resterilize surgical devices • Sales representatives who interact with Health Care Professionals and Surgery Center Staff in evaluating, identifying, and/or preparing instruments for surgical procedures INDICATIONS FOR USE AND CONTRAINDICATIONS: Instruments and delivery systems are general accessories used to facilitate: • implantation of orthopedic medical devices, or • preparation and application of bone cement to fix orthopedic medical devices to living bone, or • point of care processing or application of autologous blood and/or bone marrow component(s) or to facilitate bone graft handling. Consequently, indications and contraindications are not applicable for these types of devices. Where used uniquely for a particular implant system, consult that system’s labeling for the detailed indications, contraindications, performance characteristics, and expected clinical benefit for the devices. The clinical benefits of the instruments are primarily to facilitate appropriate alignment, sizing, implantation, and explantation of associated implants. WARNINGS AND PRECAUTIONS • Correct 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. • Do not reshape or bend instruments in any way. Do not use an instrument that has become bent from its original shape as this will affect the performance of the instrument. Bent instruments should be disposed of. • Do not reuse instruments or devices labeled for single use only. Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents. • Metal instruments or fragments can be located by radiography or fluoroscopy. Nonmetal instruments or fragments may not be located by radiography or fluoroscopy, and should be accounted for at the end of the surgical procedure. • 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 risks. • The surgeon is to be familiar with the equipment, instruments, surgical technique and surgical procedure prior to performing surgery. • Surgical instruments should only be used for their intended purpose. • Specialized instruments are designed for Biomet® implant systems to aid in the proper implantation of Biomet fixation or prosthetic components. The use of instruments or implant components from other systems can result in inaccurate fit, incorrect sizing, excessive wear and device failure. • Intraoperative fracture or breaking of instruments has been reported for general instruments. • Biomet recommends that all instruments be regularly inspected for wear and disfigurement prior to use. All trial, packaging, and instrument components must be removed prior to closing the surgical site. Do not implant.  • • • • • • • •  •  • •  • •  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. Instruments that have experienced extensive use or excessive force are susceptible to fracture. The patient is to be warned by his/her physician of all surgical risks. Unless otherwise indicated, instruments are NOT STERILE and must be thoroughly cleaned and sterilized prior to use. Instruments must be thoroughly cleaned prior to sterilization. Instruments that are not clean may not be effectively sterilized. Automated cleaning using a washer/disinfector alone may not be effective for complex instruments with lumens, cannulations, blind holes, mated surfaces and other features. Do not clean soiled instruments while in polymer or metal trays. Soaking in disinfectants may be a necessary step to control certain viruses. However, these agents may discolor or corrode instruments (household bleach contains or forms chlorine and chloride in solution and has a corrosive effect similar to saline). Disinfectants containing glutaraldehyde, or other aldehydes may denature protein based contaminants, causing them to harden and making them difficult to remove. Where possible, soaking in disinfectants should be avoided. on the package label) Instruments are for single use only and are not reusable. These devices Single Use (indicated by are single-use but can be reprocessed if not used unless labeling indicates the instrument is not to be reprocessed. Note: not used refers to those single-use components that have not been in contact with blood, bone, tissue, or other body fluids. Any unused, single-use device that has been exposed to blood, bone, tissue, or body fluids must not be reprocessed and must be discarded. Single-use devices must be cleaned separately from soiled instruments. 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. Ethylene Oxide (EO), Gas Plasma, and Dry Heat sterilization methods are not recommended for sterilization of Biomet devices. The presence of substances greater than a concentration of 0.1% weight/weight which are carcinogenic, mutagenic, symbol. or toxic to reproduction (CMR), or endocrine disruptors (ED), are identified on the product label with the  RESPONSIBILITIES OF THE USER A. Cleaning/Disinfection The health care facility is responsible to ensure that conditions essential to safe handling and cleaning/disinfection can be achieved. ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides 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 for detailed guidelines related to instrument assembling and disassembling, which can be found at: https://www.zimmerbiomet.com/medical-professionals.html. B. Sterilization The health care facility is responsible for ensuring that any packaging method or material, including a reusable rigid container system, is suitable for use in sterilization processing and sterility maintenance in a particular health care facility. ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides guidelines for preparation and assembly, sterilizer loading and unloading, matching the container system to the appropriate sterilization cycle, quality assurance, sterile storage, transport, and aseptic use. C. Complaint and Adverse Event Reporting Any product complaints shall be reported to Zimmer Biomet using the Product Experience Report (Form number CF04001) to product.experience@zimmerbiomet.com. Serious adverse events shall also be reported to the Competent Authority of the respective European Union Member State which the event occurred. CARE AND HANDLING OF INSTRUMENTS Surgical instruments and instrument cases are susceptible to damage for a variety of reasons, which includes prolonged use, misuse, and rough or improper handling. Care must be taken to avoid compromising the performance of the surgical instruments and instrument cases. To minimize damage and risk of injury, the following should be reviewed: • See Reusable Instrument Lifespan Manual 1219 for guidance on determining reusable instrument suitability for use, which can be found at https://www.zimmerbiomet.com/medical-professionals.html. • Inspect the instruments for damage and completeness upon receipt and after each use and cleaning. Instruments in need of repair should be set aside for repair service or returned to Biomet. Instruments returned to Biomet or its distributors should be cleaned and sterilized prior to shipment. ANSI/AAMI ST79 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities provides guidelines for return, or contact Biomet or your distributor for further instruction. • Only use an instrument for its intended purpose. • When handling sharp instruments, use extreme caution to avoid injury. Consult with an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact.  Page 1 of 3
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