BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER

    MDR report key: 19471303 · Received June 5, 2024

    Report

    Report Number
    1220246-2024-04980
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    September 22, 2022
    Report Date
    June 5, 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 ONE SCREW USED TO ASSEMBLE THE CUTTING INSERT IS MISSING. THE SCREW WAS NOT RETURNED FOR INVESTIGATION. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 09/22/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-28 PLATE CUTTER AND AR-18720P-12 Y-PLATE ARE MALFUNCTIONING. " PLATE WAS ATTEMPTED TO BE CUT USING MINIFRAG PLATE CUTTER THAT WAS MISSING A SCREW AND IT CUT THE PLATE IMPROPERLY.". THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807574 PLATE CUTTER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. PLATE CUTTER 671935 00888867317833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown