BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T20 HEXALOBE DRIVER, STRAIGHT (AO)

    MDR report key: 20460943 · Received October 16, 2024

    Report

    Report Number
    1220246-2024-08143
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 24, 2024
    Report Date
    August 15, 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

    VISUAL EVALUATION OF THE CUSTOMER-PROVIDED PICTURES NOTED AN AR-8970-08 T20 HEXALOBE DRIVESHAFTS WERE WARPED. REFER TO ATTACHMENTS. THE COMPLAINT ALLEGATION IS CONFIRMED BASED ON THE CUSTOMER-PROVIDED PICTURES. BASED ON THE INFORMATION PROVIDED, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO OVER-TORQUING THE SCREW WHEN INSERTING INTO THE PLATE AND/OR HARD BONE.

    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
    1375594 T20 HEXALOBE DRIVER, STRAIGHT (AO) ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. T20 HEXALOBE DRIVER, STRAIGHT (AO) 1392144 00888867309814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown