BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL/PROBE/TAP DRIVER

    MDR report key: 2912142 · Received January 11, 2013

    Report

    Report Number
    1723170-2013-00021
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    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

    RMA ISSUED. REPLACEMENT DEVICE SHIPPED TO SITE (B)(4) 2012. MEDTRONIC EVALUATION OF RETURNED SUSPECT DEVICE FOUND THAT THERE WERE NOT ABLE TO GET THE DRIVE TO COME APART WITHOUT USING TOOLS. THE DRIVE SHAFT DOES COMES UNSCREWED FROM THE DRIVE WHEN USING PLIERS AND VICE-GRIPS. WEAR DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE AWL/PROBE/TAP (APT) DRIVER BROKE INTO TWO PIECES WHILE IN A POSTERIOR SPINE FUSION FROM T2-S1. THE PROCEDURE WAS COMPLETED WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16303 AWL/PROBE/TAP DRIVER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 111025

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR