BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND DISSECTING TOOL

    MDR report key: 4092605 · Received September 16, 2014

    Report

    Report Number
    1625507-2014-00050
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE TOOL FRACTURE FACE IS CONSISTENT WITH BRITTLE IN PLANE BENDING WITH MODERATE TO HIGH STRAIN RATE. ATTEMPTS TO REPRODUCE A FAILURE CONSISTENT WITH THIS RETURNED TOOL HAVE ONLY BEEN SUCCESSFUL WHEN THE TOOL WAS NOT ROTATING AND A LATERAL ROTATION WAS INDUCED (PRYING). THE MOST LIKELY CAUSE OF FAILURE WAS AN ATTEMPT TO SNAP THE REMAINING BRIDGE OF BONE CONNECTING THE FLAP WITH A PRYING ACTION WHEN TOOL WAS NOT ROTATING. THE USER MANUAL CONTAINS THE FOLLOWING WARNING ¿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.¿ WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISSECTING TOOL BROKE DURING CRANIOTOMY PROCEDURE WHILE TURNING FLAP. THE BROKEN PIECE WAS REMOVED WITHOUT DIFFICULTY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TOOL. THERE WAS NO PATIENT IMPACT AND NO SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571295 LEGEND DISSECTING TOOL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC POWERED SURGICAL SOLUTIONS N/A H13V0303

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR