BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORPEDO, 4.0MM X 13CM

    MDR report key: 13995146 · Received April 4, 2022

    Report

    Report Number
    1220246-2022-04697
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 4, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFA
    UDI-DI
    00888867043657
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Description of Event or Problem · 0

    THE BLADE FELL APART PRODUCING SHARDS/METAL DEBRIS IN THE JOINT. THE SURGEON REMOVED/FLUSHED OUT DEBRIS. NO KNOWN ADVERSE EVENTS AT THIS STAGE. THE SALES REPRESENTATIVE SPOKE DIRECTLY TO THE CUSTOMER AFTER THE EVENT / ON THE DAY. ACCORDING TO THEATRE STAFF, THE SHAVER WAS IN OSCILLATION AGG MODE (AGGRESSIVE) INITIAL SETTING APPROX. AT 1500 RPM. THE SURGEON ASKED FOR A SPEED INCREASE TO MAX SPEED AT 3000 RPM AS WAS NOT HAPPY WITH RESECTION PERFORMANCE. THE SURGEON REPORTED GRINDING FEELING/FEEDBACK IN THE HANDPIECE WITH METAL SHARDS COMING OUT. THE SHARDS WERE COLLECTED AND WASHED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473187 TORPEDO, 4.0MM X 13CM BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA ARTHREX, INC. TORPEDO, 4.0MM X 13CM 14701884 00888867043657

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown