BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERS LEVER-LOCKING BROACH HANDLE

    MDR report key: 21411722 · Received February 19, 2025

    Report

    Report Number
    1220246-2025-00547
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    February 4, 2025
    Report Date
    March 28, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867290464
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT A THREADED PIECE WAS BROKEN OFF INSIDE OF ONE OF THE 20° L HOLE OF THE UNIVERS REVERS¿ LEVER-LOCKING BROACH HANDLE. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A USER ERROR OF THE DEVICE DUE TO MISALIGNMENT INSERTION, AND/OR PRYING/LEVERAGING OF THE MATING DEVICE DURING INSERTION.

    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

    ON 02/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9510-01 VERSION ROD HAD THE TIP BREAK OFF INSIDE THE AR-9510-2 UNIVERS REVERS LEVER-LOCKING BROACH HANDLE. A SECONDARY BROACH HANDLE AND VERSION ROD WAS PRESENT IN THE SET AND WAS USED TO COMPLETE THE CASE. NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2539248 REVERS LEVER-LOCKING BROACH HANDLE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. REVERS LEVER-LOCKING BROACH HANDLE 052317-R 00888867290464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown