BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS REVERS APEX IMPACTOR/EXTRACTOR

    MDR report key: 21093497 · Received January 7, 2025

    Report

    Report Number
    1220246-2025-09249
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 10, 2024
    Report Date
    May 29, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867301870
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9511-2, UNIVERS REVERS¿ IMPACTOR / EXTRACTOR ADAPTER, BATCH 052224, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION FOUND THAT THE DEVICE'S 135° THREADED HOLE HAS A FRAGMENT STUCK INSIDE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED MISUSE DUE PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 12/31/2024: THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024. THERE WAS NO CASE DELAY AND NO ADVERSE EFFECTS ON THE PATIENT.

    Description of Event or Problem · 0

    ON 12/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9511-2 UNIVERS REVERS IMPACTOR / EXTRACTOR ADAPTER BROKE OFF AND NO LONGER WORKS AS INTENDED, AND THE AR-9512 ARTHREX UNIVERS REVERS¿ STEM/CUP EXTRACTION ADAPTER HANDLE SHEARED OFF WHILE THREADED INTO THE AR-9511-2 UNIVERS REVERS IMPACTOR / EXTRACTOR ADAPTER. ALL PIECES THAT BROKE FROM BOTH DEVICES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT AR-9511-2 UNIVERS REVERS IMPACTOR / EXTRACTOR ADAPTER. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322209 UNIVERS REVERS APEX IMPACTOR/EXTRACTOR ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERS REVERS APEX IMPACTOR/EXTRACTOR 052224 00888867301870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown