BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T4, SELF RETAINING,MINI AO

    MDR report key: 20426726 · Received October 11, 2024

    Report

    Report Number
    1220246-2024-08094
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 20, 2024
    Report Date
    July 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867313781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, 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/OVER-ENGAGING THE DRIVER WITH THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 09/20/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-18700-09 DRIVER SHAFT WAS TWISTED. THIS OCCURRED DURING A CASE THAT CARRIED ON AND WAS COMPLETED SUCCESSFULLY WITH BACKUP PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326146 DRIVER SHAFT, T4, SELF RETAINING,MINI AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T4, SELF RETAINING,MINI AO 1392025 00888867313781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown