BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL POST/SCREW TREPHINE

    MDR report key: 22203306 · Received June 13, 2025

    Report

    Report Number
    1220246-2025-02431
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 19, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867298729
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: D9, G3, H3, H6. ONE UNPACKAGED AR-9662-R, CENTRAL POST/SCREW TREPHINE, BATCH NUMBER: 022145, WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION NOTED THAT THE DEVICE'S BODY HAD SIGNS OF WEAR, INCLUDING FADED LASER MARKS, GRIND MARKS, AND DULL CUTTING EDGES, WHICH ARE LIKELY RELATED TO THE COMPLAINT ALLEGATION. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR. DUE TO CONTINUOUS MECHANICAL FORCES APPLIED TO IT, THE DEVICE WILL INEVITABLY SUSTAIN DAMAGE OVER TIME. THE MANUFACTURING DATE WAS 2021. REFER TO INVESTIGATION PHOTOS. THE COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 05/19/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-9662-R CENTRAL POST/SCREW TREPHINE WAS DEFECTIVE. THE SURGEON USED THE TREPHINE TO REMOVE A POST DURING A REVISION OF THE TOTAL SHOULDER. NOW, A METAL POST AND BONE CANNOT BE REMOVED FROM THE TREPHINE, MAKING IT UNUSABLE. A CASE WAS INVOLVED, AND NO PATIENT WAS AFFECTED. ADDITIONAL INFORMATION RECEIVED ON 06/03/24: THE PATIENT HAD A TOTAL SHOULDER ARTHROPLASTY PREVIOUSLY AND TORE THEIR ROTATOR CUFF, SO THE SURGEON REVISED THE TSA TO A REVERSE TOTAL SHOULDER. EXACTECH TOTAL SHOULDER WAS EXPLANTED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569914 CENTRAL POST/SCREW TREPHINE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. CENTRAL POST/SCREW TREPHINE 022145 00888867298729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown