BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND DISSECTING TOOL

    MDR report key: 2250118 · Received September 15, 2011

    Report

    Report Number
    1625507-2011-00122
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION NOTED THAT THE DEVICE WAS RECEIVED IN TWO PIECES AND THE FRACTURE WAS PLANAR. THE FRACTURE SURFACE WAS SMEARED DUE TO THE TWO SURFACES RUBBING AGAINST EACH OTHER. THE TOOL FRACTURED DUE TO APPLYING A SIDE LOAD ON THE TOOL. ON FOLLOW-UP 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

    A REPORT WAS RECEIVED STATING THAT A "BURR BROKE WHILE IN SURGERY, INSIDE PATIENT BUT NO PATIENT IMPACT." ON FOLLOW-UP IT WAS NOTED THAT ALL THE PIECES WERE RECOVERED AND IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND DISSECTING TOOL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS N/A 0005665497

    Patients

    Seq Age Sex Outcome Treatment
    1