BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CN LOCK SCREW, F THREAD, Ø4.0MM X 46MM

    MDR report key: 22587325 · Received July 24, 2025

    Report

    Report Number
    1220246-2025-03048
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    January 24, 2024
    Report Date
    October 17, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KTW
    UDI-DI
    00848665033663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTIONS, AND ADDITIONAL FIELD DATA, ARTHREX WAS ABLE TO DETERMINE THE MOST LIKELY CAUSE OF THE REPORTED ISSUE. ACCORDING TO THE DOCUMENTED EVENT DETAILS, THE INADVERTENT RETENTION OF THE TARGETER/DRILL GUIDE FROM THE INITIAL PROCEDURE WAS MOST LIKELY DUE TO USER ERROR ASSOCIATED WITH SUBOPTIMAL SURGICAL TECHNIQUE. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.

    Description of Event or Problem · 0

    ON 6/27/2025, A PATIENT'S LEGAL REPRESENTATIVE REPORTED VIA EMAIL THAT THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF A COMMINUTED FRACTURE OF THE LEFT HUMERAL NECK ON (B)(6) 2024. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED ONGOING COMPLICATIONS, INCLUDING PERSISTENT PAIN, NONUNION OF THE FRACTURE, AND SIGNIFICANT DISCOMFORT WITH ANY MOVEMENT OF THE LEFT SHOULDER. ON (B)(6) 2024, THE PATIENT WAS INFORMED THAT A TARGETER/DRILL GUIDE HAD BEEN INADVERTENTLY RETAINED FROM THE INITIAL PROCEDURE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REMOVE THE RETAINED INSTRUMENT, DEBRIDE THE INFECTED AREA, AND REPLACE THE SURGICAL HARDWARE. ADDITIONAL INFORMATION RECEIVED ON 7/2/2025: DURING THE REVISION SURGERY ON (B)(6) 2024, THE FOLLOWING COMPONENTS WERE REMOVED: ONE 3022-005 PROXIMAL HUMERAL PLATE; TWO 8110-032 CORTICAL SCREWS; TWO 8110-035 CORTICAL SCREWS; ONE 8110-040 CORTICAL SCREW; ONE 8110-045 CORTICAL SCREW; ONE 8124-040 FULLY THREADED CANCELLOUS LOCKING SCREW; ONE 8124-044 FULLY THREADED CANCELLOUS LOCKING SCREW; THREE 8124-046 FULLY THREADED CANCELLOUS LOCKING SCREWS; TWO 8124-048 FULLY THREADED CANCELLOUS LOCKING SCREWS; AND ONE 8124-050 FULLY THREADED CANCELLOUS LOCKING SCREW. THE REMOVAL OPERATIVE REPORT CONFIRMED THAT THE ALIGNMENT GUIDE, ALL SCREWS, AND THE ORIGINAL PLATE WERE REMOVED. THE PATIENT¿S NON-UNION WAS REVISED DURING THE SAME PROCEDURE USING A LONGER PLATE AND SCREWS. THE MANUFACTURER OF THE NEWLY IMPLANTED HARDWARE IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187325 CN LOCK SCREW, F THREAD, Ø4.0MM X 46MM FIXATN NAIL/BLADE/PLATE COMBO KTW ARTHREX, INC. CN LOCK SCREW, F THREAD, Ø4.0MM X 46MM 0000AOS 00848665033663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other