BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY,HANDPIECE,40KHZ

    MDR report key: 11285974 · Received February 5, 2021

    Report

    Report Number
    0001825034-2021-00100
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Report Date
    January 15, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PXR
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS SHIPPED TO CONTRACT MANUFACTURER AND RECEIVED ON AUG 10, 2020. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND BREACHED INSULATION WITH EXPOSED WIRES AT THE JUNCTION BETWEEN THE CORD AND THE HAND PIECE. THE DEVICE WAS IN FIELD USE FOR 28 YEARS AND SHOWED SIGNS OF WEAR. MAINTAINING BOTH LOANED AND PURCHASED MEDICAL EQUIPMENT IN THE OPERATING ROOM TAKES A MULTIDISCIPLINARY APPROACH BY THE HEALTH CARE ORGANIZATION TO PROVIDE BOTH END USER SAFETY AND PATIENT SAFETY. HEALTH CARE ORGANIZATIONS ARE REQUIRED TO FOLLOW MANUFACTURING RECOMMENDATIONS THAT ARE PROVIDED TO ENSURE THE SAFETY OF THE MEDICAL EQUIPMENT USED WITHIN THEIR FACILITIES. THERE ARE SEVERAL ORGANIZATIONS THAT PROVIDE GUIDANCE AND RECOMMENDATIONS OF BEST PRACTICES TO HEALTHCARE ORGANIZATIONS SUCH AS THE ASSOCIATION OF PERIOPERATIVE REGISTERED NURSES (AORN). AORN'S GUIDELINES FOR PERIOPERATIVE PRACTICE PROVIDE DIRECTION FOR ACHIEVING EXCELLENCE IN PERIOPERATIVE PATIENT CARE AND WORKPLACE SAFETY. THESE EVIDENCE-BASED GUIDELINES ARE INTENDED FOR USE BY PERIOPERATIVE PROFESSIONALS TO PROMOTE SAFETY AND OPTIMAL OUTCOMES FOR PATIENTS. AORN STANDARDS INCLUDE ESTABLISHING STANDARD OPERATING PROCEDURES FOR MANAGING LOANED INSTRUMENTS AND OTHER MEDICAL DEVICES TO INCLUDE RESPONSIBILITIES OF THE DEVICE LENDER AND HEALTH CARE ORGANIZATION IN COMMUNICATION REGARDING INVENTORY, PROCESSING, INSPECTING, MAINTENANCE, AND RETURN OF PRODUCT IN ACCORDANCE WITH THE MANUFACTURER'S IFUS. NEXT, THE AORN POSITION STATEMENT ON ENVIRONMENTAL RESPONSIBILITY RECOMMENDS REFURBISHING INSTRUMENTS AND EQUIPMENT WITH PROACTIVE MAINTENANCE AND REPAIRS. ADDITIONALLY, HOSPITAL STAFF ARE REQUIRED TO ANNUALLY REVIEW EQUIPMENT MAINTENANCE AND ELECTRICAL SAFETY STANDARDS TO BE COMPLIANT WITH (B)(4), AND JOINT COMMISSION REGULATIONS. OSHA STANDARD 1910.334(A)(2)(II) STATES IF THERE IS A DEFECT OR EVIDENCE OF DAMAGE THAT MIGHT EXPOSE AN EMPLOYEE TO INJURY, THE DEFECTIVE OR DAMAGE ITEM SHALL BE REMOVED FROM SERVICE, AND NO EMPLOYEE MAY USE IT UNTIL REPAIRS AND TESTS NECESSARY TO RENDER THE EQUIPMENT SAFE HAVE BEEN MADE. FURTHERMORE, CMS REGULATION 482.21 STATES THAT FACILITIES, SUPPLIES, AND EQUIPMENT MUST BE MAINTAINED TO ENSURE AN ACCEPTABLE LEVEL OF SAFETY AND QUALITY. LASTLY, IT IS THE AORN STANDARD AND CLINICAL BEST PRACTICE FOR HEALTH CARE PROFESSIONALS TO EXAMINE ALL INSTRUMENTS AND EQUIPMENT FOR ANY COMPLICATIONS OR DEFECTS PRIOR TO THE START OF AND AT THE END OF EVERY PROCEDURE. IF ANY COMPLICATIONS OR DEFECTS ARE IDENTIFIED, THE INSTRUMENT(S) OR EQUIPMENT IS SENT FOR REPAIR WITH EITHER THE MANUFACTURER'S REPRESENTATIVE OR A THIRD PARTY PROCESSOR. SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USE AND INSTRUMENTS WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE ARE SUSCEPTIBLE TO FRACTURE. ZIMMER BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT. THE PROBABLE CAUSE WAS DEVICE WEAR AND NOT FOLLOWING IFU RECOMMENDATIONS HOWEVER A DEFINITIVE ROOT CAUSE IS NOT DETERMINED. THE DEVICE WAS REPAIRED AND INSPECTED TO SUPPLIER PROCEDURES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE SURGEON WAS REMOVING AN IMPLANT FROM THE RIGHT FEMUR WHEN THE ELECTRICAL CABLE CAUGHT ON FIRE. THE FIRE WAS IMMEDIATELY EXTINGUISHED AND THE EQUIPMENT REMOVED FROM THE FIELD. THERE WAS NO REPORTED HARM OR INJURY TO THE PATIENT OR STAFF AND THE STERILE FIELD REMAINED INTACT. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE REPORTER AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186633 ASSY,HANDPIECE,40KHZ BONE CEMENT INSTRUMENT PXR ZIMMER BIOMET, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR