BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL PROBE TAP DRIVER

    MDR report key: 2058714 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00470
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    October 19, 2010
    Report Date
    October 19, 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

    PER RMA A REPLACEMENT APT DRIVER WAS SENT TO SITE. UPON EVAL OF RETURNED DRIVER, THE DRIVER IS LOCKED UP AND WILL NOT ROTATE. OTHERWISE, THE DRIVER ACCEPTS HANDLE AND INSTRUMENTS WITHOUT ISSUE.

    Description of Event or Problem · 1

    MEDTRONIC REP REPORTED THE AWL PROBE TAP DRIVER (APT) IS LOCKED UP AND WILL NOT ROTATE. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AWL PROBE TAP DRIVER STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 091217

    Patients

    Seq Age Sex Outcome Treatment
    1