BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER

    MDR report key: 19494136 · Received June 8, 2024

    Report

    Report Number
    1220246-2024-05322
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    November 2, 2022
    Report Date
    June 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT CONFIRMED. UPON VISUAL INSPECTION IT WAS NOTED THAT BOTH SCREWS USED TO ASSEMBLE THE CUTTING INSERT IS MISSING. THE SCREWS WERE NOT RETURNED FOR INVESTIGATION. DUE TO THE MISSING SCREWS, THE CUTTING INSERT IS NO LONGER ASSEMBLED TO THE DEVICE. THE REPORTED CONDITION IS MOST LIKELY CAUSED BY OVERSTRESSING A DEVICE THAT IS DAMAGED NATURALLY AND INEVITABLY AS A RESULT OF NORMAL WEAR OR AGING.

    Description of Event or Problem · 0

    ON 11/02/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-18700-28 PLATE CUTTERS SCREWS FELL OUT. THIS OCCURRED IN A CASE WHILE USING THE CUTTER, THE SCREWS JUST FELL OUT. THERE WAS NO PATIENT EFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265722 PLATE CUTTER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. PLATE CUTTER 672036 00888867317833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown