BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 21113541 · Received January 9, 2025

    Report

    Report Number
    1220246-2025-09316
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    December 4, 2024
    Report Date
    June 10, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 PRYING/LEVERAGING THE DRIVER WHILE ENGAGED WITH THE SCREW.

    Description of Event or Problem · 0

    ON 12/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 3) OF AN AR-8737-38 DRIVER SHAFT, T10 HEX, CANNULATED BROKE WHEN ATTEMPTED TO REMOVE THREE 3.5 FULLY THREADED HEADLESS COMPRESSION SCREWS IN THE MIDFOOT REGION WHILE USING PROPER TECHNIQUE. THEY TRIED TO USE THE ARTHREX MINI TREPHINE, AND AFTER MANY ATTEMPTS, THEY USED A NON-ARTHREX PRODUCT TO CORE AROUND THE HEADLESS COMPRESSION SCREWS TO REMOVE THEM. NO PIECES BROKE OFF INSIDE THE PATIENT REPORTED. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A MIDFOOT HARDWARE REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325336 UNK INTRAMED FIXATN ROD AND ACCESS HRS ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other