BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE CUTTER

    MDR report key: 17054446 · Received June 2, 2023

    Report

    Report Number
    1220246-2023-06834
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 9, 2023
    Report Date
    October 30, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867317833
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED. ONE UNPACKAGED AR-18700-28 SERIAL/BATCH NUMBER (B)(6) WAS RECEIVED FOR INVESTIGATION. MANUAL FUNCTIONAL TESTING FOUND THAT THE DEVICE WAS WORKING AS REQUIRED. HOWEVER, THE INSTRUMENT WAS NOT USED TO CUT ANY PART. VISUAL EVALUATION NOTED DISCOLORATION MARKS. PER DRAWING C18004 AT REVISION 3 COMPONENT DESCRIPTION. ITEM 7. SILICONE INSERT (NOT SHOWN) IT IS INFERRED THAT THE INSTRUMENT HAS A SILICONE COMPONENT. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-28 PLATE CUTTERS SILICONE PIECE CAME OUT. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897651 PLATE CUTTER ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. PLATE CUTTER 672231 00888867317833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown