BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    MDR report key: 2102859 · Received April 12, 2011

    Report

    Report Number
    1723170-2011-00958
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K971247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISPOSABLE AND THERE IS NO MANUFACTURE DATE INFORMATION AT THE TIME OF THIS REPORT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AND NO RETURN IS EXPECTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A BIOPSY CASE, WHILE ATTACHING THE NAVIGUS STRAIGHT EXTERNAL BASE TO THE SKULL, THE DISPOSABLE NAVIGUS SCREWDRIVER BENT AT THE TIP (THE TIP TWISTED) AND BECAME UNUSABLE. RATHER THAN OPEN ANOTHER NAVIGUS TRAJECTORY GUIDE KIT, THE SURGEON OPTED TO USE A SYNTHES SET SCREWDRIVER TO COMPLETE THE ATTACHMENT OF THE NAVIGUS BASE WITH THE REMAINING SCREW. THE BIOPSY PROCEEDED WELL AND AS PLANNED. HOWEVER, WHILE REMOVING THE NAVIGUS BASE SCREWS, ANOTHER ONE OF THE SCREWS BROKE OFF AT THE HEAD OF THE SCREW. THEY WERE ABLE TO BITE OFF MOST OF THE REMAINDER OF THE SCREW. THE BIOPSY WENT WELL AND WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 066201310

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR