BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID INSERTER/IMPACTOR, LARGE

    MDR report key: 22686911 · Received August 1, 2025

    Report

    Report Number
    1220246-2025-03191
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 11, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867377134
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. VISUAL EVALUATION NOTED THAT THE BLUE COMPONENT OF THE DEVICE WAS BROKEN OFF. LASER LINES WERE FADED/OXIDIZED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE OF THE DEVICE IN THE FIELD. MANUFACTURED DATE 2021.

    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 07/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9241-03 GLENOID INSERTER/IMPACTOR BROKE. THE INSTRUMENT WAS USED CORRECTLY BUT THE BLUE IMPACTOR PIECE BROKE OFF THE SILER INSERTER. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239586 GLENOID INSERTER/IMPACTOR, LARGE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. GLENOID INSERTER/IMPACTOR, LARGE 37622125 00888867377134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown