BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND DISSECTING TOOL

    MDR report key: 1885484 · Received October 14, 2010

    Report

    Report Number
    1625507-2010-00059
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVAL DETERMINED THAT THE TOOL FRACTURED NEAR THE PROXIMAL END OF THE CUTTING FLUTES. THE ASSOCIATED AF02 WAS ALSO EVALUATED AND NO DEVIATIONS WERE NOTED. ON F/U, IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THE USER MANUAL CONTAINS 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 PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOOL BROKE DURING A PROCEDURE. THE BROKEN PIECE WAS QUICKLY AND EASILY RETRIEVED. THERE WAS NO PT IMPACT. ON F/U, 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 HBE MDT POWERED SURGICAL SOLUTIONS NA 0004219811

    Patients

    Seq Age Sex Outcome Treatment
    1 AF02, (B)(4)