BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM HEX DRIVER

    MDR report key: 18858864 · Received March 7, 2024

    Report

    Report Number
    1220246-2024-01359
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 22, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 COMPLAINT IS CONFIRMED. VISUAL EVALUATION IDENTIFIED THAT THE HEX DRIVE GEOMETRY AT THE DISTAL TIP OF THE RETURNED 3.0MM HEX DRIVER HAD TWISTED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGED DISTAL TIP OF THE DEVICE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 2/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9625 3.0 MM HEX DRIVER (BATCH: 021846) END HAD A TWISTED THREAD AND AN AR-9625 3.0 MM HEX DRIVER (BATCH: 1022234) SNAPPED OFF AT THE QUARTER OF AN INCH FROM THE TIP OF THE DRIVER. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880669 3.0MM HEX DRIVER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. 3.0MM HEX DRIVER 021846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown