BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FHL IMPLANT SYSTEM, 6.25 MM

    MDR report key: 22793242 · Received August 13, 2025

    Report

    Report Number
    1220246-2025-03463
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 25, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867315174
    PMA / PMN Number
    K051726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE BEING USED DURING INSERTION OF THE SCREW.

    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 SEMS (B)(4) THAT AN AR-1562BC-CP FHL IMPLANT SYSTEMS SCREW BROKE. THIS OCCURRED DURING A CASE WHEN THE SURGEON WENT TO ADVANCE THE TENODESIS SCREW THE SCREW BROKE. THEY WERE ABLE TO REMOVE IT, DISCARD AND REPLACE IT WITH ANOTHER. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66126 FHL IMPLANT SYSTEM, 6.25 MM BONE FIXATION SCREW/PLATE HWC ARTHREX, INC. FHL IMPLANT SYSTEM, 6.25 MM 15034790 00888867315174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown