BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 23196473 · Received October 1, 2025

    Report

    Report Number
    1644408-2025-01398
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    September 4, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2023-00324; 804-03-051, S110 - THREADS DAMAGED/GALLED, INSTRUMENT FAILURE. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPACTING THE GLENOID INTO THE BASEPLATE, THE HANDLE TIP BROKE OFF INSIDE THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319491 DJO SURGICAL GLENOID HEAD INSERTER/IMPACTOR HWA ENCORE MEDICAL, L.P. 274186L02

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other