BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CN LOCK SCREW, F THREAD, Ø4.0MM X 38MM

    MDR report key: 19043935 · Received April 4, 2024

    Report

    Report Number
    1220246-2024-01817
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 12, 2024
    Report Date
    June 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033625
    PMA / PMN Number
    K080590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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

    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 DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    ON 3/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8124-034 CN LOCK SCREW, F THREAD 4.0MM X 34MM, CN LOCK SCREW, F THREAD 4.0MM X 36MM, AN 8124-036 CN LOCK SCREW, F THREAD, AND QTY. 2 OF AN 8124-038 CN LOCK SCREW, F THREAD 4.0MM X 38MM FROM LOANER SET RAR-9912S WAS NOT FUNCTIONING AND DID NOT LOCK INTO THE PLATE. THIS WAS DISCOVERED DURING A PROXIMAL HUMERUS ORIF PROCEDURE. THE CASE WAS DELAYED BY APPROXIMATELY 60 MINUTES. THE SCREWS WERE INSERTED ON POWER INITIALLY AND TIGHTENED BY HAND. THE PILOT HOLES WERE DRILLED WITH POWER. THE CASE WAS COMPLETED WITH 4.0 PARTIALLY THREADED SCREWS. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83802 CN LOCK SCREW, F THREAD, Ø4.0MM X 38MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 38MM 213039 00848665033625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown