BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITINOL COMPRESSION STAPLE, 9W X 10L

    MDR report key: 19139575 · Received April 18, 2024

    Report

    Report Number
    1220246-2024-02141
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    March 22, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    JDR
    UDI-DI
    00888867287921
    PMA / PMN Number
    K203180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 CAN BE ATTRIBUTED TO MISALIGNED INSERTION; OR PRYING/LEVERAGING THE DEVICE DURING USE.

    Description of Event or Problem · 0

    ON 03/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8717-0910 DYNANITE NITINOL STAPLE PULLED THROUGH AND APPEARED TO CRUMBLE THE BONE. THE CASE WAS COMPLETED BY REMOVING THE STAPLE AND PINNING THE PATIENT'S TOE WITH A K-WIRE. THIS WAS DISCOVERED DURING A FIRST PHALANGEAL AKIN OSTEOTOMY PROCEDURE ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584243 NITINOL COMPRESSION STAPLE, 9W X 10L STAPLE, FIXATION, BONE JDR ARTHREX, INC. NITINOL COMPRESSION STAPLE, 9W X 10L 3205133575 00888867287921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other