BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 1.45 DIA GUIDEWIRE, BLU

    MDR report key: 4242813 · Received November 11, 2014

    Report

    Report Number
    1526439-2014-12075
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS USING THE VIPER2 GUIDWIRE TO HELP FACILITATE THE DIRECTION/ENTRY OF A CANNULATED PEDICLE SCREW. THE GUIDEWIRE BROKE AFTER THE SCREW WAS PLACED, WHEN REMOVING THE GUIDEWIRE. IT WAS REPORTED THAT A BROKEN PORTION MAY HAVE REMAINED IN THE BONE BUT THAT IT WAS HARD TO DETERMINE. REPORTS NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO DELAY. THE SAMPLE WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726165 VIPER2 1.45 DIA GUIDEWIRE, BLU ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 CANNULATED PEDICLE SCREW, CAT# UNKNOWN