BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID INSERTER/IMPACTOR, MEDIUM

    MDR report key: 21125110 · Received January 10, 2025

    Report

    Report Number
    1220246-2025-09348
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 16, 2024
    Report Date
    February 18, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867377127
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE POLY INSERTER/IMPACTOR WAS BROKEN OFF FROM UNIVERS VAULTLOCK® GLENOID INSERTER / IMPACTOR, MEDIUM. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED DURING THE INSERTION AND/OR REMOVAL PROCESS OF THE DEVICE OVER REPEATED USAGE.

    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 (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9241-02 GLENOID INSERTER/IMPACTOR BROKE DURING THE CASE. IT IS NOW MISSING THE SOFT BLUE COMPONENT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657728 GLENOID INSERTER/IMPACTOR, MEDIUM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. GLENOID INSERTER/IMPACTOR, MEDIUM UNK 00888867377127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown