BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 3150138 · Received June 6, 2013

    Report

    Report Number
    1625507-2013-00028
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 14, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. A PORTION OF THE FOOT OF THE ATTACHMENT WAS DETACHED AND MISSING. THE LIKELY CAUSES ARE IDENTIFIED AS DEBRIS IN THE COLLET AND IMPROPER INSERTION OF THE TOOL. (B)(4) WAS INITIATED TO INVESTIGATE THIS MALFUNCTION. IT WAS ALSO NOTED THE FOOT WAS BENT. THE USER MANUAL CONTAINS THE FOLLOWING WARNING ¿DO NOT USE A LEGEND ATTACHMENT IF ANY PART OF THE ATTACHMENT APPEARS TO BE BENT, LOOSE, MISSING, OR DAMAGED.¿ ADDITIONAL WARNING INDICATES ¿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.¿ THE PREVENTIVE MAINTENANCE/SERVICE MANUAL FOR THE LEGEND SYSTEM SPECIFIES SERVICE INTERVALS FOR DEVICES BASED ON THE HOSPITAL USAGE LEVEL. THE MAXIMUM SPECIFIED SERVICE INTERVAL IS 24 MONTHS. DEVICE HAS BEEN IN USE FOR APPROXIMATELY 82 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    REPAIR REQUEST INITIATED FOR DEVICE WITH THE REPORT OF "FOOT DETACHED." NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED TO COMPLAINT BASED ON REASON FOR RETURN. UPON EVALUATION, ATTACHMENT WAS IDENTIFIED TO BE DAMAGED BY TOOL CONTACT. NO ADDITIONAL INFORMATION WAS AVAILABLE ON FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251231 LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1