BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING,MINI AO

    MDR report key: 23122823 · Received September 23, 2025

    Report

    Report Number
    1220246-2025-04069
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. COMPLAINT ALLEGATION IS NOT CONFIRMED. 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 OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATEDLY TORQUING/ENGAGING THE DRIVER WITHIN THE SCREW HEAD AND EXTENDED USE IN THE FIELD. MANUFACTURING DATE 2019.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18700-15 DRIVER SHAFT TIP BROKE OFF WHEN TIGHTENING THE SCREW. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201147 DRIVER SHAFT, T6, SELF RETAINING,MINI AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING,MINI AO 1391942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown