BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, SELF RETAINING, AO

    MDR report key: 22921777 · Received August 29, 2025

    Report

    Report Number
    1220246-2025-03675
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 20, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385566
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. ONE UNPACKAGED AR-18800-03, BATCH 1392411, WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT THE DRIVER TIP WAS TWISTED/BENT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. 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. REFER TO INVESTIGATION PHOTOS. COMPLAINT ALLEGATION IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 08/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVE SHAFT IS WARPED. NOTICED AFTER STERILIZATION WITH NO PATIENT EFFECT. ADDITIONAL INFO 8/14/25: THE DRIVER WARPED DURING THE CASE. THE TIP SHEARED OFF IN THE SCREW HEAD CAUSING THE DOCTOR TO HAVE TO PICK IT OUT WITH A DENTAL PICK. THE PIECE WAS DISPOSED OF IN THE OR. THEY CONTINUED THE CASE WITH THE SECONDARY DRIVER SHAFT IN THE SET. NO SIGNIFICANT DELAY OR ADVERSE EFFECTS WERE EXPERIENCED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163182 DRIVER SHAFT, T6, SELF RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, SELF RETAINING, AO 1392411 00888867385566

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown