BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100 MM DISPOSABLE PIN

    MDR report key: 2942201 · Received February 4, 2013

    Report

    Report Number
    1723170-2013-00070
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. MEDTRONIC EVALUATION OF RETURNED SUSPECT DEVICE FINDS THE DEVICE IS MISSING THE SILICON CORD AT THE END OF THE PIN. MISSING PIECES FOR THE MANUFACTURE DIRECTLY CAUSED EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT A SITE 100MM DISPOSABLE PIN WAS MISSING THE INNER RUBBER RING. SINCE THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46192 100 MM DISPOSABLE PIN NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 111213

    Patients

    Seq Age Sex Outcome Treatment
    1