BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERS LEVER-LOCKING BROACH HANDLE

    MDR report key: 18483992 · Received January 10, 2024

    Report

    Report Number
    1220246-2024-00236
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 13, 2023
    Report Date
    August 27, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867290464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9510-2 LEVER-LOCKING BROACH HANDLE BATCH NUMBER: 170802-RW WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION NOTED THAT THE DEVICE HAD WEAR- THE DEVICE WAS DISCOLORED AND HAD SCRATCHES. FURTHER OBSERVATION NOTED THAT THE BROACH HANDLE LOCKING HANDLE WOULD NOT LOCK SECURELY. FUNCTIONAL TESTING WAS PERFORMED BY ATTACHING AN AR-9510-14 RASP/TRIAL STEM BATCH NUMBER: 250120700R TO THE LEVER-LOCKING BROACH HANDLE AND HITTING THE DEVICE WITH AN AR-2966 KIRK MALLET BATCH NUMBER: 6671619. AS SOON AS THE DEVICE WAS STRUCK, IT UNLOCKED AND DETACHED FROM THE AR-9510-14 RASP/TRIAL STEM. THE MOST LIKELY CAUSE FOR THESE FAILURES CAN BE ATTRIBUTED TO WEAR AND TEAR INCURRED FROM REPEATED USAGE - DATE OF MANUFACTURE 2022. REFER TO INVESTIGATION PHOTOS.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-2 REVERS LEVER-LOCKING BROACH HANDLE IS NOT FUNCTIONING WELL. WHEN IT CLICKS IN THE BROACH, IT DOESN¿T ALWAYS HOLD THE BROACH IN PLACE. THIS WAS DISCOVERED DURING A PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143077 REVERS LEVER-LOCKING BROACH HANDLE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. REVERS LEVER-LOCKING BROACH HANDLE 170802 00888867290464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown