BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TAP (CANNULATED)

    MDR report key: 3071442 · Received April 22, 2013

    Report

    Report Number
    1723170-2013-00296
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND SHOWED SIGNS OF A MECHANICAL FAILURE MODE. AS REPORTED, A GUIDE WIRE WAS LODGED INTO THE TAP FROM THE TAP END. IT WAS NOT POSSIBLE TO REMOVE THE WIRE. THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS REPLACED AND THERE WERE NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SITE WAS ATTEMPTING TO REMOVE BONE FROM THE 5.5MM TAP USING A STYLET AND THE STYLET BECAME STUCK IN THE TAP. THE SITE WAS REPORTED UNABLE TO REMOVE THE STYLET FROM THE TAP. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173179 5.5MM TAP (CANNULATED) NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 121024

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR