BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CN LOCK SCREW, F THREAD, Ø4.0MM X 42MM

    MDR report key: 21536611 · Received March 6, 2025

    Report

    Report Number
    1220246-2025-00820
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    October 29, 2024
    Report Date
    September 5, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033649
    PMA / PMN Number
    K080590
    Adverse Event
    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 IS A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON 2/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A PROXIMAL HUMERUS FRACTURE PROCEDURE ON (B)(6) 2023. A 3024-011 LEFT ALPHA PLATE, AN AR-8935-24 LOW PROFILE SCREW, TITANIUM, NON-LOCKING, AN 8110-026 CORTICAL BONE SCREW, AN 8110-024 CORTICAL BONE SCREW, TWO 8110-028 CORTICAL BONE SCREW, TWO 8124-036 CANCELLOUS LOCKING SCREW, TWO 8124-044 CANCELLOUS LOCKING SCREW, AN 8124-032 CANCELLOUS LOCKING SCREW, AN 8124-048 CANCELLOUS LOCKING SCREW, AN 8124-046 CANCELLOUS LOCKING SCREW, THREE 8114-026 DOUBLE LEAD LOCK CORTICAL SCREW, AN 8124-042 CANCELLOUS LOCKING SCREW, AN 8124-038 CANCELLOUS LOCKING SCREW, AND AN 8124-030 CANCELLOUS LOCKING SCREW WERE IMPLANTED. DUE TO NONUNION, THE PATIENT UNDERWENT A SECOND SURGERY ON (B)(6) 2024 TO HAVE AN AR-18827P-16 20 HOLE REINFORCED STRAIGHT PLATE, AN AR-18827-30 CORTICAL SCREW, AR-18827-18 CORTICAL SCREW, AR-18827V-18, AN AR-18827V-16 VAL SCREW, AN AR-18827V-22 VAL SCREW, TWO AR-18827V-20 VAL SCREW AN AR-18827V-10 VAL SCREW, AND AN ABS-2010-10 ALLOSYNC PURE IMPLANTED. ALL THE PREVIOUSLY IMPLANTED PRODUCTS DURING THE INITIAL SURGERY ON (B)(6) 2023 REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799662 CN LOCK SCREW, F THREAD, Ø4.0MM X 42MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 42MM 220897 00848665033649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown