BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .045" GUIDE WIRE TROCAR, THREADED

    MDR report key: 22124436 · Received June 2, 2025

    Report

    Report Number
    1220246-2025-02338
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    April 20, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    NBH
    UDI-DI
    00888867127203
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 MISALIGNED INSERTION; PRYING/LEVERAGING THE DEVICE DURING INSERTION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A COMPETENT AUTHORITY REPORTED VIA EMAIL THAT THE TIP OF AN AR-8737-42 THREADED GUIDE WIRE BROKE INTRAOPERATIVELY INSIDE THE PATIENT'S RIGHT WRIST. THE SURGEON ATTEMPTED RETRIEVAL BUT WAS UNSUCCESSFUL, AND THE TIP REMAINS IN THE PATIENT'S WRIST. THE SURGEON AND SURGICAL TEAM HAVE BEEN MADE AWARE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 5/12/2025: THE ORTHOPEDIC PROCEDURE WAS SUCCESSFULLY COMPLETED. THE SURGERY EXPERIENCED A 15-MINUTE DELAY BEFORE PROCEEDING AS PLANNED. HOWEVER, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT BEYOND THE INITIAL PREPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603767 .045" GUIDE WIRE TROCAR, THREADED ARTHROSCOPIC ACCESSORIES NBH ARTHREX, INC. .045" GUIDE WIRE TROCAR, THREADED UNK 00888867127203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown