BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SHAFT, T-15, MEDIUM

    MDR report key: 11990561 · Received June 14, 2021

    Report

    Report Number
    1220246-2021-03258
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867225190
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT DURING UNIVERSE REVERS AND MGS REVERS SHOULDER REPLACEMENT SURGERIES THE DEVICES AR-9545-T15-02 (LOT 8001928, 8001545, 8001643, 8002005), AR-9545-T15-03 (LOT 00888867225190, 00888607225190) AND AR-9625 (LOT 021924) BENT/TWIST AND BROKE WHEN INSERTING THE CENTRAL AND PERIPHERAL SCREWS INTO THE BASEPLATES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENTS. ACCORDING TO THE SURGEONS NO HARM FOR PATIENTS, OPERATORS OR THIRD PARTY OCCURRED. THE SURGERIES WERE FINISHED SUCCESSFULLY WITH NEW DEVICES WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893228 DRIVER SHAFT, T-15, MEDIUM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. DRIVER SHAFT, T-15, MEDIUM 8002005 00888867225190

    Patients

    Seq Age Sex Outcome Treatment
    1