BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID INSERTER/IMPACTOR, LARGE

    MDR report key: 22850241 · Received August 20, 2025

    Report

    Report Number
    1220246-2025-03545
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    August 4, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867377134
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. COMPLAINT ALLEGATION IS CONFIRMED BY THE ATTACHED PICTURE, WHICH SHOWS THE IMPACTOR HEAD BROKEN OFF FROM THE IMPACTOR BASE. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE DURING THE INSERTION AND/OR REMOVAL PROCESS OF THE DEVICE IN THE FIELD. MANUFACTURED DATE 2021.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07008709 THAT AN AR-9241-03 GLENOID INSERTER/IMPACTOR AUGMENTED VAULT LOCK INSERTER BROKE. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295867 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