BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T4, NON-RETAINING, MINI AO

    MDR report key: 19668335 · Received July 3, 2024

    Report

    Report Number
    1220246-2024-06572
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 6, 2024
    Report Date
    January 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867313781
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    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 IS ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO OVER-TORQUING/OVER-ENGAGING THE DRIVER WITHIN THE SCREW HEAD.

    Description of Event or Problem · 0

    ON 06/06/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-18700-09 DRIVER SHAFT AND AN AR-18700-29 DRIVER SHAFTS TIPS BROKE OFF. THIS OCCURRED DURING A CASE WHERE THE DRIVERS BROKE OFF INTO THE AR-1871V-08 SCREW HEAD IN THE AR-18714P-12 PLATE. ONE OF THE TIPS FROM AN AR-18700-29 DRIVER COULD NOT BE RETRIEVED AS IT COLD WELDED TO THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281783 DRIVER SHAFT, T4, NON-RETAINING, MINI AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T4, NON-RETAINING, MINI AO UNK 00888867313781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown