BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER

    MDR report key: 15698166 · Received October 31, 2022

    Report

    Report Number
    1220246-2022-05667
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    May 18, 2022
    Report Date
    November 14, 2022
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT CUTTING INSERT HAD BROKEN OFF. THE INSERT WAS NOT RETURNED FOR INVESTIGATION. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF WEAR AND TEAR DAMAGE ACCUMULATED OVER REPEATED USAGE.

    Additional Manufacturer Narrative · 0

    DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED. COMPLAINT CONFIRMED. UPON VISUAL INSPECTION, IT WAS NOTED THAT CUTTING INSERT HAD BROKEN OFF. THE INSERT WAS NOT RETURNED FOR INVESTIGATION. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF WEAR AND TEAR DAMAGE ACCUMULATED OVER REPEATED USAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-18700-28 PLATE CUTTER IS DAMAGED NON-SPECIFICALLY. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351785 PLATE CUTTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. PLATE CUTTER 672014 00888867317833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown