BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 23763846 · Received December 9, 2025

    Report

    Report Number
    1644408-2025-01895
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 14, 2025
    Report Date
    April 14, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    FZX
    UDI-DI
    00190446266068
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SEE H4, H6, H10 AND H11. COMPLAINT HAS BEEN EVALUATED AND IS SIMILAR TO REPORT NUMBER 1644408-2022-01145; S-201106, S303-BROKE/CRACKED/DAMAGED, INSTRUMENT FAILURE. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    PATIENT PRESENTED WITH ARTHRITIS OF THE GLENOHUMERAL JOINT, IT WAS DECIDED TO INITIATE SURGERY FOR A REVERSE TOTAL SHOULDER REPLACEMENT. DURING SURGERY, THE BASEPLATE WAS IMPLANTED AND THE SHORT 4 BARREL DRILL GUIDE WAS PLACED ONTO THE BASEPLATE DURING INSERTION OF THAT INSTRUMENT (8-201106), A PORTION OF CENTRAL SCREW OF THE DRILL GUIDE BROKE OFF IN THE BASEPLATE. AFTER SEVERAL ATTEMPTS TO REMOVE THE SCREW AND THE BASEPLATE (ABOUT 25-30 MINUTES) IT WAS DETERMINED TO RELY ON THE MORSE TAPERS ON THE GLENOSPHERE AND FORGO THE RETAINING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554680 DJO SURGICAL SPECIAL, SHORTENED RSP BASEPLATE DRILL_SCREW GUIDE FZX ENCORE MEDICAL L.P. S-201106 111-11-111 00190446266068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization