BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 2.0 X 18MM, CORTICAL

    MDR report key: 22751334 · Received August 8, 2025

    Report

    Report Number
    1220246-2025-03375
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    March 17, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867311763
    PMA / PMN Number
    K220937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    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 DESCRIPTIONS, AND ANY ADDITIONAL FIELD INFORMATION, ARTHREX WAS ABLE TO DETERMINE THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE(S) FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR, IMPROPER BONE PREPARATION, MISALIGNED INSERTION, OR EXCESSIVE FORCES THROUGH LEVERAGING/PRYING THE DEVICE. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RECEIVED FOR EVALUATION, AND NO EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 07/22/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-18720-20 CORTICAL SCREW AND AN AR-18720-18 CORTICAL SCREW BROKE. THIS OCCURRED DURING A PILON FRACTURE ON (B)(6) 2025. THE SCREW REMAINS IN THE PATIENT, WHO HAD NORMAL BONE QUALITY. THERE WAS NO DELAY IN THE PROCEDURE, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING A LARGER SCREW IN THE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224005 LOW PROFILE SCREW, 2.0 X 18MM, CORTICAL BONE FIXATION SCREW/PLATE HRS ARTHREX, INC. LOW PROFILE SCREW, 2.0 X 18MM, CORTICAL 00888867311763

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown