BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T8, SELF RETAINING, AO

    MDR report key: 21314529 · Received February 5, 2025

    Report

    Report Number
    1220246-2025-00216
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 6, 2025
    Report Date
    September 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867316270
    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

    ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 THE MOST LIKELY CAUSE. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THE FAILURE WAS RECEIVED.

    Description of Event or Problem · 0

    ON 01/13/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-18700-54 DRIVER SHAFT WAS WARPED. THIS OCCURRED DURING AN F&A RECONSTRUCTION ON (B)(6) 2025 THAT WAS COMPLETED USING A BACKUP DRIVER IN THE SET. THERE WAS NO DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63784 DRIVER SHAFT, T8, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T8, SELF RETAINING, AO 1392312 00888867316270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown