BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAV 5.5MM TAP (CANNULATED)

    MDR report key: 3002376 · Received March 13, 2013

    Report

    Report Number
    1723170-2013-00176
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INCORRECT PATIENT DATA WAS PROVIDED ON INITIAL MDR. CORRECT INFORMATION NOW PROVIDED. REPLACEMENT TAP SENT TO SITE FOR ISSUE RESOLUTION. EVALUATION OF SUSPECT TAP CONFIRMS REPORTED ISSUE: AS REPORTED, THE TIP OF THE INSTRUMENT HAS BEEN BROKEN OFF. OTHERWISE, THE INSTRUMENT INSERTED INTO A NAVLOCK AND ROTATED WITHOUT ISSUE.

    Additional Manufacturer Narrative · 1

    PATIENT AGE WAS UNAVAILABLE FROM THE SITE AT TIME OF THIS REPORT.NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A HOSPITAL STAFF MEMBER REPORTED A TIP WAS BROKEN OFF ON THEIR 5.5 TAP. THE BROKEN TIP WAS IDENTIFIED PRIOR TO SURGERY. SURGEON DECIDED TO PROCEED WITH THE CASE USING THE DAMAGED TAP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105444 NAV 5.5MM TAP (CANNULATED) NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 110103

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR