BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV CD HORIZON SOLERA 4.75MM DRIVER

    MDR report key: 2121754 · Received May 20, 2011

    Report

    Report Number
    1723170-2011-00984
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE NOT AVAILABLE AT THIS TIME. AS REPORTED, THE TIP OF THE TOOL HAS BEEN TWISTED, DIRECTLY CAUSING EVENT. THE RETURNED PRODUCT DID NOT MEET SPECIFICATIONS. AS REPORTED, THE TIP OF THE TOOL WAS TWISTED. THE DEVICE MALFUNCTION WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. A REPLACEMENT PART WAS SENT TO THE SITE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT HE WENT TO THE SITE TO DO AN EVALUATION WITH THE SOLERA SCREW SET. WHEN THE SURGEON WAS PUTTING THE SCREW ON THE SOLERA DRIVER THE THREADS ON THE DRIVER THAT ENGAGE WITH THE SCREW TWISTED AND BROKE OFF. THIS HAPPENED WHILE SETTING UP FOR A CASE. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY WITHOUT THE USE OF THE DRIVER. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAV CD HORIZON SOLERA 4.75MM DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 101221

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR