BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED TOOL LEGEND, F2/8TA23

    MDR report key: 1191922 · Received October 1, 2008

    Report

    Report Number
    1625507-2008-00060
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. 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 RECEIVED INDICATING THAT THE TOOL BROKE DURING USE. THERE WAS NO PT IMPACT REPORTED. THE TOOL WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

    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 SOLUTIONS NA 0000756746

    Patients

    Seq Age Sex Outcome Treatment
    1