BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER, T10 HEXALOBE

    MDR report key: 23817023 · Received December 16, 2025

    Report

    Report Number
    1220246-2025-05629
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 25, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867053045
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    ADDITIONAL INFORMATION: D9, G3, H3, H6 ONE UNPACKAGED AR-8944DH BATCH 130964 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE DRIVER TIP WAS TWISTED AND BENT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR WITH THE DEVICE, RESULTING FROM OVER-TORQUING/OVER-ENGAGING THE INSERTER WITHIN THE SCREW DURING USE. THE COMPLAINT ALLEGATION WAS CONFIRMED. REFER TO THE INVESTIGATION PHOTOS.

    Description of Event or Problem · 0

    ON 11/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8944DH DRIVER TIP WAS TWISTED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED ON 12/2/2025: IT WAS FURTHER REPORTED THAT THIS OCCURRED DURING A CLAVICLE FRACTURE PROCEDURE, AND THE CASE WAS COMPLETED WITH ANOTHER DRIVER. NO PATIENT HARM OR CASE DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60460 DRIVER, T10 HEXALOBE MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. DRIVER, T10 HEXALOBE 130964 00888867053045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown