BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35MM TAP

    MDR report key: 21665401 · Received March 21, 2025

    Report

    Report Number
    1220246-2025-01123
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    March 11, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867298491
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    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. THE REPORTED EVENT IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY SURGERY THE TIP BROKE INSIDE THE GLENOID. THE BROKEN PEACE WAS REMOVED. 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
    796535 35MM TAP ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 35MM TAP 022325 00888867298491

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown