BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND DISSECTING TOOL

    MDR report key: 2132896 · Received June 17, 2011

    Report

    Report Number
    1625507-2011-00084
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MDT 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 FRACTURE SURFACE IS PERPENDICULAR TO THE STEM. THE FRACTURE SURFACE AND GEOMETRY ARE CONSISTENT WITH A TOOL BREAKING DUE TO PLANE BENDING. THE ATTACHMENT WAS EVALUATED AND THE BEARINGS WERE IN GOOD CONDITION. IT WAS NOTED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. THE DAMAGE IS ONLY COSMETIC IN NATURE AS THE FOOT IS CAPABLE OF PROTECTING THE TOOL FROM CONTACTING THE DURA. THE USER MANUAL CONTAINS THE FOLLOWING WARNING "THE ATTACHMENT SHOULD NOT BE USED IF ANY PART OF THE ATTACHMENT APPEARS TO BE BENT, LOOSE, MISSING, OR DAMAGED. EXCESSIVE PRESSURE OR IMPROPER HANDLING, SUCH AS BENDING OR PRYING, OF THE ATTACHMENT OR DISSECTING TOOL MAY CAUSE INJURY TO THE PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS PENDING EVALUATION. IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. 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."

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TOOL BROKE DURING A PROCEDURE. THERE WAS NO PATIENT IMPACT AND THE DETACHED PORTION WAS EASILY RECOVERED.

    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 0004463815

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR (B)(4)