BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOPFS

    MDR report key: 3175131 · Received May 23, 2013

    Report

    Report Number
    3009730153-2013-00003
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 22, 2013
    Manufacturer
    BLUE BELT TECHNOLOGIES (BBT)
    Product Code
    OLO
    PMA / PMN Number
    K121936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING THE NAVIOPFS SYSTEM TO IMPLANT A UNICONDYLAR KNEE IMPLANT. WHEN ENTERING THE CUTTING MODE, THE NAVIOPFS SYSTEM GENERATED A HAND PIECE EXPOSURE CONTROL MOTOR ERROR INDICATING A HIGH TORQUE REQUIRED TO MOVE THE MOTOR, AS IF THE BURR HAD JAMMED. THE SURGEON AND THE BBT CLINICAL SPECIALIST CHECKED FOR JAMS AND COULD NOT FIND ANY ISSUES. THE SURGEON CHANGED TO THE BACKUP HAND PIECE AND HAD THE SAME ISSUE. THE SURGEON DECIDED TO ABORT USE OF THE NAVIOPFS SYSTEM AND REVERT TO A MANUAL TOTAL KNEE IMPLANT PROCEDURE. THE BBT CLINICAL SPECIALIST COMPLETED AN INVESTIGATION ON SITE AND FOUND THAT THE CAUSE OF THE MALFUNCTION WAS THAT THE HOSPITAL'S STERILE SERVICES DEPARTMENT HAD ADDED A PIECE OF TAPE FOR IDENTIFICATION TO THE LONG ATTACHMENT WHICH CAUSED THE MALFUNCTION. THE TAPE PREVENTED PROPER COUPLING OF THE LONG ATTACHMENT WHEN ASSEMBLING THE HAND PIECE. TAPE WAS REMOVED AND THE HAND PIECE FUNCTIONED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229771 NAVIOPFS 882.4560 STEROTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES (BBT) NAVIO PFS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention