BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 1915167 · Received December 6, 2010

    Report

    Report Number
    1625507-2010-00075
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. IT WAS ALSO NOTED THAT SIGNS OF INTERNAL CORROSION WERE EVIDENT. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. 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."

    Description of Event or Problem · 1

    REPAIR REQUEST INITIATED AND ESCALATED TO COMPLAINT FOR THE DEVICE WITH A REPORT THAT THE ATTACHMENT FOOT WAS CUT BY A TOOL. NO PATIENT IMPACT REPORTED. ON FOLLOW-UP, IT WAS NOTED THAT THIS WAS IDENTIFIED DURING A PROCEDURE AND IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1