BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    520MM NITINOL GUIDEWIRE DOUBLE BLUNT AND THREADED

    MDR report key: 3750808 · Received January 29, 2014

    Report

    Report Number
    2032593-2014-00002
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS CONCERNING THE SAME PATIENT SURGERY (SEE MFG REPORT NUMBER 2032593-2014-00001). IT WAS REPORTED THE 520MM NITINOL GUIDEWIRE, DOUBLE BLUNT AND THREADED TIPS BROKE DURING SURGERY. THIS REPORT CONCERNS LOT NUMBER 520MM NITINOL GUIDEWIRE, DOUBLE BLUNT AND THREADED LOT NUMBER: M013982E. IT WAS REPORTED: "TIPS BROKE DURING SURGERY". ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2014. DURING A L5-S1 POSTERIOR SPINAL FUSION (PSF) SURGERY THE KWIRES WERE PLACED IN THE VERTEBRAL BODIES AND THEN THE SURGEON "TAPPED" FOR SCREWS. WHEN THE SURGEON ATTEMPTED TO PULL THE KWIRE, THEY REALIZED THAT THE K WIRE HAD BROKEN. THERE WAS NO ALLEGED INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT; THIS WAS DISCOVERED IMMEDIATELY UPON BREAKAGE. NO PART OF THE GUIDE WIRE WAS LEFT INSIDE THE PATIENT OR SURGICAL SITE. THE TIP WAS REMOVED WITH A GRASPER AND VIA A "JAM SHIDI" NEEDLE. A CONFIRMATION X-RAY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62435 520MM NITINOL GUIDEWIRE DOUBLE BLUNT AND THREADED NEWPORT NKB SEASPINE, INC. M013982E

    Patients

    Seq Age Sex Outcome Treatment
    1