BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORPEDO, 4.0MM X 13CM

    MDR report key: 12076382 · Received June 28, 2021

    Report

    Report Number
    1220246-2021-03344
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 8, 2021
    Report Date
    June 28, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    UDI-DI
    00888867043657
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 A PROCEDURE, THE SURGEON WAS OPERATING THE SHAVER IN AGG OSCILLATION MODE AT 3000RPM AND THE PIECE OF THE INNER LUMEN BROKE OFF. IT APPEARS THAT THIS HAPPENED WITH OUT BEING IN CONTACT WITH TISSUE OR BONE. THE PIECE WAS RETRIEVED WITH AN ARTHROSCOPIC GRASPER AND THE CASE WAS COMPLETED BY USING ANOTHER AR-8400TD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978268 TORPEDO, 4.0MM X 13CM BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA ARTHREX, INC. TORPEDO, 4.0MM X 13CM 12590633 00888867043657

    Patients

    Seq Age Sex Outcome Treatment
    1