BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KREULOCK SCREW, TI, 3.5X30

    MDR report key: 22706866 · Received August 4, 2025

    Report

    Report Number
    1220246-2025-03233
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 14, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867323261
    PMA / PMN Number
    K201132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR, INCLUDING IMPROPER BONE PREPARATION AND INCORRECT SURGICAL TECHNIQUE DURING DEVICE APPLICATION. THESE FACTORS MAY HAVE CONTRIBUTED TO THE MALFUNCTION OR COMPROMISED THE INTEGRITY OF THE IMPLANT DURING THE PROCEDURE. 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 07/16/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8935CL-30 KREULOCK¿ COMPRESSION SCREW DID NOT COMPRESS CORRECTLY. THIS OCCURRED DURING AN ANKLE FRACTURE ON (B)(6) 2025; THE DEVICE WAS REMOVED. THE PATIENT'S BONE QUALITY IS UNKNOWN; HOWEVER, IT WAS PREPPED USING AN AR-8943-DRILL BIT. THERE WAS A SLIGHT DELAY OF A MINUTE. THE CASE WAS COMPLETED USING AN AR-8935-30. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660181 KREULOCK SCREW, TI, 3.5X30 BONE FIXATION SCREW/PLATE HRS ARTHREX, INC. KREULOCK SCREW, TI, 3.5X30 00888867323261

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown