BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER

    MDR report key: 19531333 · Received June 13, 2024

    Report

    Report Number
    1220246-2024-05705
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    January 26, 2021
    Report Date
    June 13, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. ONE UNPACKAGED AR-18700-28, BATCH 671935 PLATE CUTTER WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE JAW COMPONENT AT THE DISTAL END OF THE PLATE CUTTER WAS LOOSE DUE TO MISSING SCREWS, WITH ONE PIECE RECEIVED SEPARATE FROM THE MAIN ASSEMBLY. THE SCREWS WERE NOT RETURNED FOR ANALYSIS. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF WEAR AND TEAR DAMAGE ACCUMULATED OVER REPEATED USAGE, AS FURTHER EVIDENCED BY THE PRESENCE OF HEAVY OXIDATION ACROSS THE LASER MARKINGS. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREWS ON THE AR-18700-28 HAVE COME LOOSE OVER TIME AND ARE NO LONGER IN THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955478 PLATE CUTTER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. PLATE CUTTER 671935 00888867317833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown