BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGC PATELLAR CLAMP

    MDR report key: 7002280 · Received November 5, 2017

    Report

    Report Number
    0001825034-2017-09831
    Event Type
    Malfunction
    Date Received
    November 5, 2017
    Date of Event
    October 10, 2017
    Report Date
    August 13, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED. DURING VISUAL INSPECTION IT WAS NOTED THAT THE KNOB WAS MISSING HOWEVER THE THUMB SCREW USED TO HOLD THE KNOB IN PLACE IS INSPECTED COULD BE THREADED BACK ON AND OFF. THERE WERE ALSO SCRATCHES AND NICKS ON THE INSTRUMENT. IT WAS ALSO NOTED THAT THIS DEVICE HAS BEEN IN THE FIELD FOR 17 YEARS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED DUE TO THE INABILITY TO KNOW IF THE INSTRUMENT WAS DISASSEMBLED OR FRACTURED. 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 · 1

    (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED AND ALL PARTS WERE RETURNED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781534 AGC PATELLAR CLAMP ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ZIMMER BIOMET, INC. N/A 688570

    Patients

    Seq Age Sex Outcome Treatment
    1