BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED TOOL LEGEND, F2/8TA23

    MDR report key: 1061520 · Received June 17, 2008

    Report

    Report Number
    1625507-2008-00039
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Report Date
    May 19, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTION
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMENTS: MALFUNCTION WAS CONFIRMED ON EVAL. IT WAS NOTED THAT THE FRACTURE WAS CONSISTENT WITH EXCESSIVE BENDING FORCE APPLIED TO THE TOOL WHILE CUTTING. DISSECTING TOOL BREAKAGE IS A KNOWN PROBLEM THAT MAY OCCUR DURING USE OF HIGH SPEED DISSECTING TOOLS. EXCESSIVE CUTTING FORCE OR BENDING OF TOOLS DURING USE CAN CAUSE BREAKAGE. WARNING IS PROVIDED IN DEVICE USER MANUAL INDICATING "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

    REPORT REC'D INDICATING THAT THE TOOL BROKE WHILE PERFORMING A CRANIOTOMY. THE BROKEN PIECE WAS IMMEDIATELY RETRIEVED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED TOOL LEGEND, F2/8TA23 PNEUMATIC SURG DRILL TOOL LEGEND HBB MEDTRONIC POWERED SURGICAL SOLUTION NA 5359S

    Patients

    Seq Age Sex Outcome Treatment
    1