BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERS LEVER-LOCKING BROACH HANDLE

    MDR report key: 20859788 · Received December 6, 2024

    Report

    Report Number
    1220246-2024-08724
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 7, 2024
    Report Date
    January 28, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867290464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS NOT CONFIRMED. ONE UNPACKAGED AR-9510-2, UNIVERS REVERS¿ LEVER-LOCKING BROACH HANDLE, BATCH NUMBER, 052246-R, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED SIGNS OF WEAR AND TEAR: DISCOLORATION AND STRIKE MARKS ON THE IMPACTOR HANDLE. A FUNCTIONAL TEST WITH AR-9510-14 FOUND THAT THE RETURNED DEVICE CONNECTED AND LOCKED ON TO THE MATING PART WITHOUT ISSUES. NO PROBLEM FOUND.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY THE DEVICE BROKE. THE DEVICE IS STILL STUCK IN THE DEVICE AR-9510-2, BATCH: 052246-R. THE SURGERY WAS FINISHED SUCCESSFULLY. NO FURTHER INFORMATION RECEIVED. UPDATE KPILZ 03-DEZ-2024: FURTHER INFORMATION WERE RECEIVED THAT THE DEVICE BROKE DURING A SHOULDER PROTHESIS SURGERY. THE DEVICE BROKE OUTSIDE OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377413 REVERS LEVER-LOCKING BROACH HANDLE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. REVERS LEVER-LOCKING BROACH HANDLE 052246-R 00888867290464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown