BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND DISSECTING TOOL

    MDR report key: 1800051 · Received August 11, 2010

    Report

    Report Number
    1625507-2010-00044
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 13, 2010
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FRACTURE PLANE WAS PERPENDICULAR TO THE STEM AXIS. THE FRACTURE SURFACES WERE ALSO "SMEARED" INDICATING THAT THE TWO SURFACES WERE RUBBED TOGETHER AFTER THE FRACTURE OCCURRED. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PT IMPACT. THE USER MANUAL CONTAINED THE FOLLOWING "DO NOT USE EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, ON ATTACHMENTS OR DISSECTING TOOLS. THIS MAY CAUSE TOOL TO BEND OR BREAK AND CAUSE INJURY TO PT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS USING A LEGEND MOTOR, AN AF02 ATTACHMENT AND AN F28TA23 TOOL. TOOL BROKE AS HE WAS IN THE MIDDLE OF CRANIOTOMY CUTTING THE BONE FLAP. NO PT IMPACT WAS REPORTED. ON FOLLOW-UP, IT WAS NOTED THAT THE DETACHED PORTION WAS EASILY RETRIEVED AND IT WAS CONFIRMED THAT THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND DISSECTING TOOL HBE-DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, HBE MEDTRONIC POWERED SURGICAL SOLUTIONS NA 0002019880

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR