BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T20 HEXALOBE DRIVER, STRAIGHT (AO)

    MDR report key: 20460916 · Received October 16, 2024

    Report

    Report Number
    1220246-2024-08144
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 24, 2024
    Report Date
    January 10, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867309814
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    COMPLAINT IS CONFIRMED. VISUAL EVALUATION IDENTIFIED THAT THE HEX DRIVE GEOMETRY AT THE DISTAL TIP OF THE RETURNED T20 HEXALOBE DRIVESHAFT, SOLID, STRAIGHT HAD TWISTED. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGED DISTAL TIP OF THE DEVICE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 09/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8970-08 T20 HEXALOBE DRIVESHAFTS WERE WARPED. THIS OCCURRED DURING A FOOT & ANKLE FUSION ON (B)(6)2024 WHERE THE CASE WAS COMPLETED USING A BACKUP DRIVER IN THE TRAY. THERE WAS NO DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322623 T20 HEXALOBE DRIVER, STRAIGHT (AO) ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T20 HEXALOBE DRIVER, STRAIGHT (AO) 1392329 00888867309814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown