BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER, HERCULES STYLE

    MDR report key: 12267444 · Received August 3, 2021

    Report

    Report Number
    1220246-2021-03467
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    June 24, 2021
    Report Date
    August 3, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867055254
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THE BLADE ON AR-8954-03 HERCULES PLATE CUTTER LOT: 561424 WAS BROKEN WHILE CUTTING A PLATE DURING A CASE. THE PATIENT WAS NOT HARMED AND THE CASE WAS COMPLETED BY USING A NEW AR-8954-03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168861 PLATE CUTTER, HERCULES STYLE INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM ARTHREX, INC. PLATE CUTTER, HERCULES STYLE 561424 00888867055254

    Patients

    Seq Age Sex Outcome Treatment
    1