BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER NAV3(TM) PLATFORM

    MDR report key: 4121181 · Received September 26, 2014

    Report

    Report Number
    0001811755-2014-03381
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 1, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT DUPLICATED. DURING THE DEVICE EVALUATION BY THE REPAIR TECHNICIAN, THE MAIN COMPONENTS OF THE SYSTEM WERE BOTH TESTED INDIVIDUALLY AND AS A COMPLETE SYSTEM. ALTHOUGH SOME SIGNS OF USE SUCH AS SCRATCHES AND SCUFFS WERE NOTED, THE DEVICE SUCCESSFULLY PASSED ALL TESTING AND WAS FOUND TO BE FULLY FUNCTIONAL. OTHER RADIO FREQUENCY DEVICES USING THE SAME FREQUENCY AND MODULATION IN THE VICINITY MAY HAVE DISTURBED THE RFID FUNCTIONALITY AND CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE USING PRECISION 5.0 SOFTWARE, THE STRYKER NAV3(TM) WAS FREEZING AFTER A CASE CARD WAS PUT IN THE CARD READER. IT SYSTEM WAS RESTARTED A NUMBER OF TIMES, BUT AFTER THE CAMERA COULD NOT SEE THE TRACKERS IN THE FIELD, A BACKUP SYSTEM WAS USED. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO CLINICALLY SIGNIFICANT DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT PROCEDURE USING PRECISION 5.0 SOFTWARE, THE STRYKER NAV3(TM) WAS FREEZING AFTER A CASE CARD WAS PUT IN THE CARD READER. IT SYSTEM WAS RESTARTED A NUMBER OF TIMES, BUT AFTER THE CAMERA COULD NOT SEE THE TRACKERS IN THE FIELD, A BACKUP SYSTEM WAS USED. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO CLINICALLY SIGNIFICANT DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601459 STRYKER NAV3(TM) PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1