BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CN LOCK SCREW, F THREAD, Ø4.0MM X 34MM

    MDR report key: 23004466 · Received September 9, 2025

    Report

    Report Number
    1220246-2025-03771
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION, AND/OR EXCESSIVE FORCE BEING USED DURING INSERTION OF THE SCREW.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN 8124-034 CN LOCK SCREW WOULD NOT LOCK INTO THE PLATE. THIS WAS DISCOVERED A PROXIMAL HUMERUS PROCEDURE WHICH WAS COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465990 CN LOCK SCREW, F THREAD, Ø4.0MM X 34MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 34MM 230477 00848665033601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown