BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35MM TAP

    MDR report key: 20640583 · Received November 8, 2024

    Report

    Report Number
    1220246-2024-08478
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 28, 2024
    Report Date
    January 31, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867298491
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-4020C-06 / BATCH 021811 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, THE TIP OF THE DEVICE WAS BROKEN AT THE DISTAL END. FUNCTIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED MISUSE DUE TO MISALIGNED INSERTION; OR PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    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

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9621-35T 35 MM TAP HAD THE TIP BREAK OFF. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877215 35MM TAP ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 35MM TAP 021811 00888867298491

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown