BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF CMNTLS IMPLANT INSERT

    MDR report key: 9368684 · Received November 25, 2019

    Report

    Report Number
    3002806535-2019-00890
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 28, 2019
    Report Date
    February 15, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. THE POSTERIOR FOOT IS FRACTURED. THE DENTS ON THE SUPERIOR HANDLE SURFACE AND THE TARNISH OF THE INSTRUMENT¿S BODY INDICATE THAT THE INSTRUMENT HAS BEEN USED MULTIPLE TIMES. THE POSTERIOR FOOT IS FRACTURED. THE FRACTURED FOOT HAS BEEN RETURNED. THE INFERIOR SURFACE OF THE HANDLE HAS MINOR DENTS, HOWEVER, IT IS IMPOSSIBLE TO FORM THE INFORMATION GIVEN IN THE COMPLAINT TO DETERMINE WHETHER THE DAMAGE OCCURRED DURING OPERATION, THE INSTRUMENT WAS MISUSED, OR REPROCESSING, THE INSTRUMENT WAS STERILISED WITH OTHER INSTRUMENTS IN A BASKET THAT COULD CAUSE THE SURFACE DAMAGE. BOTH BLUE REPLACEABLE PLUGS WERE NOT RETURNED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 14 SIMILAR COMPLAINTS FOR THIS ITEM CODE 32-42209 . THE EVENT OCCURRENCE HAS BEEN EXCEEDED SINCE THE COMPLETION OF THE HHE, THEREFORE, THE (B)(4) HAS BEEN RAISED TO INVESTIGATE BREACHED OCCURRENCE. THE MEMORANDUM FROM THE DEVELOPMENT TEAM ATTACHED IN THE HHE DETAILS POSSIBLE MISUSE SCENARIOS IN WHICH THE POSTERIOR TAB MAY BE SUBJECTED TO LOADING THAT COULD HAVE CAUSED THE REPORTED FRACTURE. THESE SCENARIOS ARE: 1)USE OF THE INSERTER TO FULLY IMPACT THE DEVICE, RESULTING IN POSTERIOR TAB BECOMING TRAPPED BETWEEN THE BONE AND IMPLANT. 2) USE OF EXCESSIVE FORCE WHEN TIGHTENING THE THUMB-WHEEL MAY LEAD TO HIGH ANTERIOR-POSTERIOR LOADING ON THE POSTERIOR TAB. 3)USE OF THE INSERTER TO REMOVE A PARTIALLY OR FULLY SEATED IMPLANT, BY IMPACTING AN INTERNAL SURFACE IN A DIRECTION UP AND AWAY FROM THE PATIENT; 180DEG. OPPOSITE TO THE IMPACTION REQUIRED FOR THE INSERTION. THE INSTRUCTIONS FOR REUSABLE SURGICAL INSTRUMENTS, DOC. NO. 5401000246 VERSION 2.3 (MARCH 2009), WARNS THAT: ¿¿MAINTENANCE, INSPECTION AND FUNCTIONAL TESTING: ALL INSTRUMENTS SHOULD BE VISUALLY CHECKED FOR DAMAGE AND WEAR. CUTTING EDGES SHOULD BE FREE OF NICKS AND PRESENT A CONTINUOUS EDGE. REUSABLE INSTRUMENT LIFESPAN MANUAL (219.3-GLBL-EN-REV0419) PROVIDES VERBAL AND VISUAL INSTRUCTION ON HOW TO DETECT INSTRUMENT FRACTURE. SURGICAL TECHNIQUE 0338.2-EMEA-EN CONTAINS THE FOLLOWING INSTRUCTIONS: ¿¿THE KNEE IS FLEXED FULLY AND, USING THE TOFFEE MALLET, THE COMPONENT IS THEN CAREFULLY IMPACTED. BEFORE IT IS FULLY SEATED, THE INTRODUCER/IMPACTOR IS REMOVED BY UNSCREWING THE THUMBWHEEL." ¿¿FINAL IMPACTION OF THE TIBIAL COMPONENT IS ACHIEVED WITH THE TOFFEE MALLET AND THE STANDARD IMPACTOR PLACED CENTRALLY OVER THE KNEE¿¿. 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 · 0

    IT WAS REPORTED THAT DURING SURGERY THE 'HOOK' BROKE FROM THE INSTRUMENT. NO DELAY TO SURGERY WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE 'HOOK' BROKE FROM THE INSTRUMENT. NO DELAY TO SURGERY WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE 'HOOK' BROKE FROM THE INSTRUMENT. NO DELAY TO SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168211 OXF CMNTLS IMPLANT INSERT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A ZB161004

    Patients

    Seq Age Sex Outcome Treatment
    1