BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGEND FOOTED ATTACHMENT

    MDR report key: 3031585 · Received April 2, 2013

    Report

    Report Number
    1625507-2013-00022
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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 26 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

    DEVICE RETURNED FOR NON-SPECIFIED REPAIR. NO PATIENT IMPACT REPORTED. REPAIR ESCALATED TO COMPLAINT ON DECONTAMINATION DUE TO ATTACHMENT FOOT BEING DAMAGED BY TOOL CONTACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE MALFUNCTION WAS IDENTIFIED BY THE SCRUB TECH UPON ASSEMBLY OF THE DRILL SYSTEM PRIOR TO SURGERY. A BACK-UP UNIT WAS USED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135071 LEGEND FOOTED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1