BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TAP (CANNULATED)

    MDR report key: 2963789 · Received February 15, 2013

    Report

    Report Number
    1723170-2013-00097
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC INVESTIGATION OF RETURNED SUSPECT 4.5 TAP FINDS THAT AS REPORTED, THE END OF THE INSTRUMENT IS SLIGHTLY BENT. THE TIP IS FLUTED OUT AS WELL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED AN ISSUE WITH A SOLERA 4.5MM TAP WHILE IN A SURGERY. THE TIP OF THE 4.5MM TAP IS SLIGHTLY BENT IN AREA OF THE THREADS. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE STEALTHS7 SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68765 4.5MM TAP (CANNULATED) NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 100910

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR