BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.75MM TAP (NON-CANNULATED)

    MDR report key: 3105207 · Received May 10, 2013

    Report

    Report Number
    1723170-2013-00336
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 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

    MANUFACTURE DATE WAS UNAVAILABLE AS NO LOT NUMBER WAS PROVIDED. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    SUSPECT TAP WAS RETURNED FOR EVALUATION. AS REPORTED, THE TIP OF THE INSTRUMENT IS VISIBLY BENT. OTHERWISE, THE INSTRUMENT APPEARS TO BE IN GOOD CONDITION. MATERIAL DEFORMATION DIRECTLY CAUSED EVENT. A NEW TAP WAS SENT TO THE SITE FOR ISSUE RESOLUTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A SPINE PROCEDURE, A 3.75 NON-CANNULATED TAP WAS BENT OUT OF ALIGNMENT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM AND OTHER TAPS IN THEIR SET. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206255 3.75MM TAP (NON-CANNULATED) NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 110720

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR