BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T15 SOLID HEX DRIVER

    MDR report key: 23135324 · Received September 24, 2025

    Report

    Report Number
    1220246-2025-04116
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 9, 2025
    Report Date
    November 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    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. THE COMPLAINT ALLEGATION WAS CONFIRMED. ONE UNPACKAGED 0448-100 BATCH, DATED 180302, WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE HANDLE WAS BROKEN INTO TWO PIECES. THE LASER MARKS ARE FADED, AND THERE ARE HEAVY SIGNS OF WEAR AROUND THE DEVICE. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE DEVICE'S DAMAGE. THE REPORTED CONDITION IS MOST LIKELY CAUSED BY USER ERROR, OVERSTRESSING A DEVICE THAT HAS BEEN DAMAGED NATURALLY AND INEVITABLY DUE TO NORMAL WEAR OR AGING. DEVICE MANUFACTURED DATE: 2021.

    Description of Event or Problem · 0

    ON 09/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 0448-100 T15 SOLID HEX DRIVER SNAPPED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614162 T15 SOLID HEX DRIVER FIXATN NAIL/BLADE/PLATE COMBO LXH ARTHREX, INC. T15 SOLID HEX DRIVER 180302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown