BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIST HUM FRAC PLT,EA,TI,LFT,11H,STRL

    MDR report key: 22795132 · Received August 13, 2025

    Report

    Report Number
    1220246-2025-03479
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    July 29, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867435483
    PMA / PMN Number
    K242079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 OVER-TORQUING THE SCREW WHEN INSERTING INTO THE PLATE AND/OR HARD BONE.

    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 07/29/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8935-24 SCREW BROKE WHILE GOING INTO A AR-7654EL-11S. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED BY LEAVING THE BROKEN HARDWARE IN AND USING OTHER SCREW HOLES. NO DELAY TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66248 DIST HUM FRAC PLT,EA,TI,LFT,11H,STRL BONE FIXATION PLATE HRS ARTHREX, INC. DIST HUM FRAC PLT,EA,TI,LFT,11H,STRL 15429334 00888867435483

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown