BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID INSERTER/IMPACTOR, MEDIUM

    MDR report key: 24290962 · Received February 9, 2026

    Report

    Report Number
    1220246-2026-00467
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 16, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867377127
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 THE COMPLAINT ALLEGATION HAS BEEN CONFIRMED. ONE UNPACKAGED AR-9241-02 UNIVERS VAULTLOCK® GLENOID INSERTER / IMPACTER, MEDIUM, BATCH 37622124, WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, THE BLUE MATERIAL WAS FOUND BROKEN, DETACHED FROM THE MAIN PART. IT WAS NOTED THAT THE INSTRUMENT'S LASER MARKS ARE FADED. A FUNCTIONAL TEST WAS NOT PERFORMED BECAUSE THE DEVICE WAS DAMAGED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, SPECIFICALLY EXCESSIVE FORCE IMPACTING THE DEVICE. DIRECTIONS FOR USE (DFU) DFU-0023-EO REVISION 5, INSTRUMENTS I. CAUTIONS 2. TO AVOID DAMAGING THE INSTRUMENTS, DO NOT IMPACT OR SUBJECT TO BLUNT FORCE ANY INSTRUMENTS THAT ARE DESIGNED TO BE TURNED OR SCREWED IN. WHEN TWO DEVICES ARE INTENDED TO BE THREADED TOGETHER, ENSURE THAT THEY ARE FULLY ENGAGED PRIOR TO USE.

    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) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07193575 THAT AN AR-9241-02 UNIVERS VAULTLOCK MEDIUM GLENOID INSERTER/IMPACTOR FELL APART WHEN THE SURGEON HIT IT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349863 GLENOID INSERTER/IMPACTOR, MEDIUM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. GLENOID INSERTER/IMPACTOR, MEDIUM 2797 00888867377127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown