BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLENOID INSERTER/IMPACTOR, LARGE

    MDR report key: 20864192 · Received December 6, 2024

    Report

    Report Number
    1220246-2024-08735
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 8, 2024
    Report Date
    July 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867377134
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO IMPROPER BONE PREP; MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON 11/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9241-03 UNIVERS VAULTLOCK® GLENOID INSERTER HAD THE BLUE IMPACTOR BREAK OFF DURING THE CASE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490466 GLENOID INSERTER/IMPACTOR, LARGE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. GLENOID INSERTER/IMPACTOR, LARGE 37622123 00888867377134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown