BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 20988586 · Received December 20, 2024

    Report

    Report Number
    1220246-2024-08973
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    March 20, 2024
    Report Date
    June 10, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    501

    Narratives

    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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    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 (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8737-38 DRIVER SHAFT SEEMED TO STRIP WHEN THE SCREW WAS BEING REMOVED, AND THE TIP FRACTURED OFF OF THE DRIVER. THIS OCCURRED DURING A SCREW HARDWARE REMOVAL WHERE THE CASE WAS COMPLETED SUCCESSFULLY USING THE SOLID DRIVER IN THE REMOVAL TRAY. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION WAS PROVIDED ON 4/3/2024 WHERE THE SALES REPRESENTATIVE STATED THAT THIS PROCEDURE WAS REMOVING ARTHREX PARTS, BUT THEY WERE NOT SURE WHAT THE LOT NUMBERS AND SIZES WERE, THEY WERE THE MIS BUNION BEVELED SCREWS. THE INITIAL PROCEDURE WAS A MIS BUNION CORRECTION THAT TOOK PLACE AT HAYMARKET ASC. THE SAME SURGEON DOING THE REMOVAL PLACED THE IMPLANTS. THE REPRESENTATIVE WAS NOT SURE OF THE INITIAL PROCEDURE DATE. THE DEVICES WERE REMOVED PER THE PATIENT'S REQUEST, BUT THE REPRESENTATIVE WAS NOT 100% SURE OF THE OFFICIAL REASON. THE DRIVER DID BREAK AND ALL FRAGMENTS SEEMED TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2204279 UNK INTRAMED FIXATN ROD AND ACCESS HSB ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other