BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 23042033 · Received September 12, 2025

    Report

    Report Number
    1220246-2025-03837
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 20, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. 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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO OVER-TORQUING THE SCREW WHEN INSERTING INTO THE PLATE AND/OR HARD BONE.

    Description of Event or Problem · 0

    ON 08/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07039663 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
    2594947 UNK FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown