BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM

    MDR report key: 19558941 · Received June 18, 2024

    Report

    Report Number
    1220246-2024-05937
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    February 9, 2023
    Report Date
    June 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033670
    PMA / PMN Number
    K080590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING.

    Description of Event or Problem · 0

    ON 3/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREW, 4.0 MM X 48 MM, AN 8124-05 FULLY THREADED CANCELLOUS LOCKING SCREW, 4.0 MM X 50 MM, AND AN 8128-048 PARTIALLY THREADED CANCELLOUS LOCKING SCREW4.0 MM X 48 MM HAD AN ISSUE. THIS WAS DISCOVERED DURING A PROXIMAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2023. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262750 CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 48MM UNK 00848665033670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown