BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19519562 · Received June 12, 2024

    Report

    Report Number
    1220246-2024-05608
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    December 30, 2022
    Report Date
    June 12, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033601
    PMA / PMN Number
    K080590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ALLEGATION CANNOT BE CONFIRMED WITHOUT THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO PHOTOS OF THE FAILURE WERE PROVIDED. PER THE EVENT DESCRIPTION, THE MOST LIKELY CAUSE(S) FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR, MISALIGNED INSERTION.

    Description of Event or Problem · 0

    ON 1/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 8124-034 LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A NEW 8124-034 WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373316 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 UNK 00848665033601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown