BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T10, NON-RETAINING

    MDR report key: 17480001 · Received August 8, 2023

    Report

    Report Number
    1220246-2023-07448
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 10, 2023
    Report Date
    November 21, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385603
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, H3, H6.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18800-25 DRIVER SHAFT BROKE DURING THE INSERTION OF THE 2.7MM SCREW. THE BONE SOCKET WAS PREPARED WITH A 2.0MM DRILL, THE SCREW WAS INSERTED WITH POWER, AND THE DRIVER TIP BROKE WHEN IT HIT THE PLATE. ALL THE BROKEN FRAGMENTS WERE RETRIEVED AND CONFIRMED VIA X-RAY THAT NOTHING WAS LEFT BEHIND IN THE PATIENT. ANOTHER AR-18800-25 DRIVER SHAFT WAS USED TO CONTINUE THE IMPLANTATION OF THE SCREW. THIS WAS DISCOVERED DURING A TIBIA ORIF PROCEDURE ON (B)(6) 2023.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 7/11/2023: THE AR-18800-25 DRIVER SHAFT WAS ATTACHED TO A 4400-BATTERY POWER FROM ANOTHER MANUFACTURER. THE CASE WAS NOT DELAYED, AND THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158633 DRIVER SHAFT, T10, NON-RETAINING ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. DRIVER SHAFT, T10, NON-RETAINING 1392239 00888867385603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown