BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAK NEEDLE KIT

    MDR report key: 2874200 · Received December 14, 2012

    Report

    Report Number
    1723170-2012-00731
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECTED DEVICE WAS RECEIVED BY THE MANUFACTURE AND INVESTIGATION FINDINGS INCLUDE: THE PLASTIC BASE OF THE NEEDLE IS DEFORMED WITH TOOL MARKS OR CUTS. AS A RESULT, THE NEEDLE DOES NOT FULLY SEAT INTO THE HANDLE. THE PLASTIC BASE OF THE CANNULA ALSO HAS TOOL MARKS AND WILL NOT FULLY SEAT INTO THE HANDLE. THE PIECES MUST BE FULLY SEATED FOR THE LOCKING MECHANISM TO CLOSE, SO THE LOCK WILL NOT CLOSE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT UNAVAILABLE FROM SITE AT TIME OF THIS REPORT. RMA ISSUED. TO DATE, NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A DOCTOR REPORTED, WHILE IN A SURGERY, THAT IT IS HARD TO OPEN AND CLOSE THE LOCKING MECHANISM ON THE PAK NAVIGATED PEDICLE ACCESS KIT. WHEN TAPPING ON THE PAK NEEDLE THE INNER SLEEVE BROKE AND SLID UPWARDS THROUGH THE WHITE OUTER SLEEVE. THE SURGEON COMPLETED THE SURGERY WITH THE USE OF NAVIGATION. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAK NEEDLE KIT NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120710

    Patients

    Seq Age Sex Outcome Treatment
    1