BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 2931651 · Received January 28, 2013

    Report

    Report Number
    1625507-2013-00008
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 4, 2013
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. EVALUATION DETERMINED THAT THE FOOTED PORTION WAS DAMAGED BY TOOL CONTACT. THE LIKELY CAUSES ARE IDENTIFIED AS DEBRIS IN THE COLLET AND IMPROPER INSERTION OF THE TOOL. (B)(4) WAS INITIATED TO INVESTIGATE THIS MALFUNCTION. 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 40 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR TRENDS. (B)(4).

    Additional Manufacturer Narrative · 1

    REPORT INCONCLUSIVE. NO EVALUATION COULD BE PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THIS IS A KNOWN FAILURE MODE THAT COULD OCCUR DUE TO EXCESSIVE PRESSURE, SUCH AS BENDING OR PRYING, ON DISSECTING TOOLS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DEVIATIONS WERE NOTED. 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." 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 24MONTHS. DEVICE HAS BEEN IN USE FOR APPROXIMATELY 40 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPAIR REQUEST INITIATED FOR DEVICE WITH REPORT OF ATTACHMENT DAMAGED. NO PATIENT IMPACT REPORTED. REPAIR REQUEST ESCALATED DUE TO REASON FOR RETURN. NO ADDITIONAL INFORMATION WAS AVAILABLE ON FOLLOW - UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36771 LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1