BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER SOLERA 5.5/6.0 MAS CAN

    MDR report key: 3905234 · Received July 1, 2014

    Report

    Report Number
    1723170-2014-00700
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE.DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE.DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE.RMA ISSUED. REPLACEMENT 5.5/6.0 DRIVER SHIPPED TO SITE 06/04/2014. SUSPECT PART HAS NOT BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE TIP OF THE INSTRUMENT HAS BEEN BROKEN OFF.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE, T-10-PELVIC, A SOLERA 5.5/6.0 CANNULATED DRIVER WAS BROKEN. AFTER THE SECOND SCREW WAS PLACED, THE DRIVER BROKE WHEN THE SCREW WAS THREE-FOURTHS OF THE WAY IMPLANTED. THE SURGEON UTILIZED THE NAVIGATED UNIVERSAL DRILL GUIDE (UDG) WITH A 3.0MM DRILL AND UNDER-TAPPED WITH A 6.5MM TAP AND 7.5MM SCREWS. AFTER THE NAVIGATED DRIVER WAS BROKEN, THE SURGEON USED A NON-NAVIGATED DRIVER TO CONTINUE. ALL OTHER INSTRUMENTS WERE NAVIGATED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382573 DRIVER SOLERA 5.5/6.0 MAS CAN NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 130426

    Patients

    Seq Age Sex Outcome Treatment
    1