BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUNTERSINK, 2.0MM

    MDR report key: 19482742 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05029
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    October 14, 2022
    Report Date
    June 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867312739
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE WAS NOT RECEIVED FOR EVALUATION AND NO PHOTO WAS PROVIDED; COMPLAINT NOT CONFIRMED. THE MOST LIKELY PROBABLE CAUSE OF THE EVENT IS ATTRIBUTED TO WEAR AND TEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 10/14/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-35 DEPTH DEVICE AND AR-18700-24 COUNTERSINK DEVICE IS RUSTY. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422714 COUNTERSINK, 2.0MM ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. COUNTERSINK, 2.0MM 00888867312739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown