BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERS LEVER-LOCKING BROACH HANDLE

    MDR report key: 17408405 · Received July 27, 2023

    Report

    Report Number
    1220246-2023-07331
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    June 28, 2023
    Report Date
    November 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867290464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED AR-9510-2 SERIAL NUMBER, (B)(6), WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TEST WITH AR-9510-14 FOUND THAT THE DEVICE IS FUNCTIONING AS INTENDED. WHEN THE BROACH HANDLED TRIGGER WAS PRESSED, THE MATTING PART WAS RELEASED. THE RETURNED DEVICE WAS VISUALLY INSPECTED, AND IT WAS NOTED THAT THE 20° R HOLE IS OBSTRUCTED WITH A PIECE OF PRESUMABLY MATTING PART AR-9510-01 THAT WAS BROKEN OFF INSIDE THE HOLE. THE VISUAL INSPECTION ALSO NOTED SEVERE SIGNS OF WEAR ON THE DEVICE, AS MANY SCRATCHES, DISCOLORATION, AND DENTS THROUGHOUT THE DEVICE¿S BODY. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS USER ERROR FOR APPLYING EXCESSIVE FORCE DURING USE.

    Description of Event or Problem · 0

    ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9510-2 BROACH HANDLE BROKE OFF THE THREADED PORTION OF THE VERSION ROD INTO THE 20° HOLE. THIS OCCURRED DURING A CASE, ANOTHER DEVICE WAS USED. THERE WAS NO EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323653 REVERS LEVER-LOCKING BROACH HANDLE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. REVERS LEVER-LOCKING BROACH HANDLE UNK 00888867290464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown