BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS REVERS TRIAL 42 +3

    MDR report key: 20653816 · Received November 11, 2024

    Report

    Report Number
    1220246-2024-08507
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    October 29, 2024
    Report Date
    July 8, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867062061
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. PHOTOGRAPHIC EVIDENCE PROVIDED FROM THE FIELD OF AN AR-9530L-03, WITH BATCH NUMBER 250120800, REVEALED A DAMAGED DEVICE: NICKS, CHIPS, AND IMPACT MARKS. THEREFORE, ARTHREX WAS ABLE TO DEDUCE THE CAUSE OF THE COMPLAINT AS WEAR AND TEAR.

    Description of Event or Problem · 0

    ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9619-45 45MM REAMER BROKE DURING A CASE. ALL WERE RETRIEVED, AND THE CASE WAS CONTINUED. LATER, DURING THE CASE, THE AR-9530L-03 WAS USED, AND THE REP NOTICED IT HAD A LOT OF WEAR AND TEAR AND WOULD NEED TO BE REPLACED FOR THE NEXT TIME. IT WAS USED A LOT, AND PIECES WERE FALLING OFF. THE REP CONFIRMED NOTHING FELL INTO THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT A SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795434 UNIVERS REVERS TRIAL 42 +3 ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERS REVERS TRIAL 42 +3 250120800 00888867062061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown