BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLID SCREWDRIVER, T6 HEXALOBE

    MDR report key: 19343543 · Received May 17, 2024

    Report

    Report Number
    1220246-2024-03459
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 22, 2024
    Report Date
    January 3, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867385658
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    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

    ADDITIONAL INFORMATION: G3, H3, H6. 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 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING A PROCEDURE MULTIPLE DEVICES FAILED. DURING THE PROCEDURE AN AR-18800-04 DRIVER SHAFT BECAME TWISTED, AN AR-18800-04 DRIVER SHAFT SNAPPED OFF, (2) AR-18800-03 DRIVER SHAFTS WERE TWISTED, AN AR-18700-39 TORQUE LIMITING ADAPTER WAS NOT CLICKING WHEN THE TORQUE WAS REACHED, A AR-18800-05 SOLID SCREWDRIVER WAS TWISTED, AND A AR-18700-45 POINTED REDUCTION FORCEPS WOULD NOT CLOSE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490522 SOLID SCREWDRIVER, T6 HEXALOBE ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. SOLID SCREWDRIVER, T6 HEXALOBE 1392252 00888867385658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown