BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM HEX DRIVER

    MDR report key: 19279223 · Received May 9, 2024

    Report

    Report Number
    1220246-2024-03038
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 16, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9625 SERIAL/BATCH NUMBER 022319 WAS RECEIVED FOR INVESTIGATION. THE VISUAL INSPECTION REVEALED THAT THE HEX OF THE DRIVER WAS BENT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGED TO THE DEVICE. THE MOST LIKELY CAUSE WILL BE MISUSE OF EXCESSIVE TORQUE FORCE.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 04/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9625 3.0 MM HEX DRIVER TIP BROKE. THIS OCCURRED DURING A PROCEDURE THE TIP BROKE DUE TO WEAR AND TEAR, IT HAD BEEN WARPED AND TWISTED. THE CASE WAS COMPLETED USING ANOTHER DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359259 3.0MM HEX DRIVER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 3.0MM HEX DRIVER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown