BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE SCREW, 1.6 X 10MM, CORTICAL

    MDR report key: 23004634 · Received September 9, 2025

    Report

    Report Number
    1220246-2025-03774
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867313224
    PMA / PMN Number
    K191326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. COMPLAINT ALLEGATION IS NOT CONFIRMED. 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 OF THE REPORTED FAILURE IS USER ERROR IN THE DEVICE, WHICH CAN BE ATTRIBUTED TO PRYING/LEVERAGING, MISALIGNMENT, AND/OR EXCESSIVE FORCE USED DURING IMPLANT INSERTION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18716-11 AND A AR-18716-10 LOW PROFILE SCREWS BROKE WHILE BEING IMPLANTED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495845 LOW PROFILE SCREW, 1.6 X 10MM, CORTICAL BONE FIXATION PLATE HRS ARTHREX, INC. LOW PROFILE SCREW, 1.6 X 10MM, CORTICAL 00888867313224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown