BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25MM TAP

    MDR report key: 22297306 · Received June 20, 2025

    Report

    Report Number
    1220246-2025-02585
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 28, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867298477
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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-9621-35T, 35 MM TAP WITH BATCH 022420, WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE TIP OF THE CUTTING FLUTE WAS BROKEN OFF. NO FRAGMENTS WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISALIGNED INSERTION; AND PRYING/LEVERAGING THE DEVICE DURING INSERTION. SEE EVALUATION PICTURES 3 + 4. THE REPORTED EVENT IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INVERSE SHOULDER PROSTHESIS SURGERY, THE DRILL BROKE. PER COMPLAINT REPORTER, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780544 25MM TAP ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 25MM TAP 022403 00888867298477

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown