BEUDAMED
    FDA Adverse Event Injury Summary report: N

    .045" GUIDE WIRE TROCAR, THREADED

    MDR report key: 7889531 · Received September 19, 2018

    Report

    Report Number
    1220246-2018-00650
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    September 4, 2018
    Report Date
    September 19, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    NBH
    UDI-DI
    00888867127203
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIP CASE, THE TIP OF THE GUIDEWIRE BROKE OFF. THE REP WAS NOT IN THE CASE AND HAD NO MORE INFO. HE WAS UNSURE IF IT HAD BEEN RETRIEVED. ADDITIONAL INFORMATION OBTAINED 9/7/18: CASE WAS A SCAPHOID FIX. AS THE GUIDEWIRE WAS BEING REMOVED IT WAS NOTICED THAT THE TOP WAS BROKEN. THE GUIDEWIRE WAS AN AR-8737-42, LOT 810382544. ADDITIONAL INFORMATION OBTAINED 9/11/18: IT HAS BEEN CONFIRMED THAT THE TIP OF THE DEVICE WAS NOT RETRIEVED AS IT WAS TOO DEEPLY IN THE SCAPHOID TO RETRIEVE. IT WAS FOUND AND CONFIRMED UNDER FLUORO. THE REMAINING PORTION OF THE DEVICE WAS DISPOSED OF AFTER THE CASE. THE BREAK OCCURRED JUST BEHIND THE THREADS SO NO THREADS WERE VISIBLE AFTER THE MAIN PART OF THE GUIDEWIRE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733254 .045" GUIDE WIRE TROCAR, THREADED ACCESSORIES, ARTHROSCOPIC NBH ARTHREX, INC. .045" GUIDE WIRE TROCAR, THREADED 810382544 00888867127203

    Patients

    Seq Age Sex Outcome Treatment
    1