BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APT DRIVER

    MDR report key: 2081182 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00867
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE IS UNK. PER RMA, A REPLACEMENT APT WAS SENT TO SITE. UPON EVALUATION OF RETURNED APT, THE POST IS LOOSE AND UNSCREWS EASILY. THE TIP OF THE POST THAT ATTACHES TO THE HANDLE HAS DEEP DIVOT MARKS INDICATED REPEATED IMPACTS FROM A HAMMER. NO IMPACT ON PATIENT OUTCOME REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED, THE EGG HANDLE BROKE OFF AND THE SHAFT OF AWL PROBE TAP BROKE WHEN BACKING OUT SCREW FROM PATIENT. A SPARE APT HANDLE WAS AVAILABLE TO CONTINUE CASE. NO IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APT DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 090618

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK