BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CN LOCK SCREW, F THREAD, Ø4.0MM X 24MM

    MDR report key: 19522186 · Received June 12, 2024

    Report

    Report Number
    1220246-2024-05639
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    January 26, 2023
    Report Date
    June 12, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033557
    PMA / PMN Number
    K080590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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 1/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN 8124-024 CN LOCK SCREW HAD AN ISSUE. DURING A PROXIMAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO SCREW IT INTO THE PLATE INSIDE THE PATIENT, IT WOULD NOT LOCK. THE SCREW WAS REMOVED IN ONE PIECE, NOTHING BROKE INSIDE THE PATIENT. ANOTHER SCREW WITH THE SAME PART AND LOT NUMBER WAS USED. THIS ONE DID LOCK AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THE DEVICE WAS DISCARDED, NO PICTURES WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189891 CN LOCK SCREW, F THREAD, Ø4.0MM X 24MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 24MM 213032 00848665033557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown