BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35MM TAP

    MDR report key: 21148539 · Received January 14, 2025

    Report

    Report Number
    1220246-2025-09427
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    November 27, 2024
    Report Date
    February 19, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9621-35T, 35 MM TAP, 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.

    Description of Event or Problem · 0

    ON 12/18/2024 IT WAS REPORTED, BY A SALES REPRESENTATIVE VIA (B)(4), THAT AN AR-9621-35T 35MM TAP BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2024. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898083 35MM TAP ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 35MM TAP 022420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown