BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35MM TAP

    MDR report key: 23132284 · Received September 24, 2025

    Report

    Report Number
    1220246-2025-04098
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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-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. REFER TO INVESTIGATION PHOTOS. COMPLAINT ALLEGATION IS CONFIRMED.

    Description of Event or Problem · 0

    ON 09/09/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-9621-35T 35MM TAP WAS BROKEN. NO PATIENTS WERE HARMED, AND THE SURGERY WAS NOT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598534 35MM TAP ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 35MM TAP 022420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown