BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T6, NON-RETAINING, AO

    MDR report key: 17890291 · Received October 6, 2023

    Report

    Report Number
    1220246-2023-08098
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 5, 2022
    Report Date
    October 25, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385573
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS 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.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 9/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 SELF RETAINING DRIVE SHAFT AND AN AR-18800-04 NON-RETAINING DRIVER SHAFT HAD AN ISSUE. WHILE INSERTING A CORTICAL SCREW, THE AR-18800-03 SELF RETAINING DRIVE SHAFT STARTED TO TORQ OUT AND WASN'T RETAINING SCREWS. THE DEVICE WAS SWITCHED TO AN AR-18800-04 NON-RETAINING DRIVER SHAFT, AND WHILE INSERTING ANOTHER SCREW, THE DRIVER'S HEAD BROKE OFF INSIDE THE SCREW HEAD. THE PIECE WAS RECOVERED, AND THE CASE WAS COMPLETED BY SWITCHING TO A SOLID BLUE HANDLE T6 DRIVER IN THE TRAUMA MINI FRAG TRAY 2.0 SCREW CADDY. THIS WAS DISCOVERED DURING A MET SHAFT FRACTURE PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 9/19/2023: THERE WAS A 1-5 MINUTE DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342607 DRIVER SHAFT, T6, NON-RETAINING, AO ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T6, NON-RETAINING, AO 1392241 00888867385573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown