BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGEND ANGLED ATTACHMENT

    MDR report key: 4092292 · Received September 16, 2014

    Report

    Report Number
    1625507-2014-00049
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    June 23, 2014
    Report Date
    May 21, 2015
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE USER MANUAL CONTAINS THE FOLLOWING ¿HEAVY SIDE LOADS AND/OR LONG OPERATING PERIODS MAY CAUSE THE DEVICE TO OVERHEAT. IF OVERHEATING OCCURS: NEVER PLACE AN OVERHEATED MOTOR ON THE PATIENT OR DRAPING DURING SURGERY. DISCONTINUE USE AND REST THE MOTOR BY USING INTERMITTENTLY, OR WRAP THE MOTOR/ATTACHMENT INTERFACE WITH A MOIST STERILE TOWEL. IF THE MOTOR IS PASSED OFF, THE RECEIVER SHOULD GRASP THE MOTOR BY THE PROXIMAL END CLOSE TO THE MOTOR HOSE. TO AVOID INJURY TO THE PATIENT OR USER, DO NOT PLACE THE HANDPIECE ON THE PATIENT OR IN AN UNSECURED LOCATION, WHEN NOT IN USE.¿ IN ADDITION, ¿CONTINUOUS CUTTING FOR EXTENDED PERIODS MAY CAUSE THE DEVICE TO HEAT TO AN UNCOMFORTABLE TEMPERATURE.¿ MAXIMUM CONTINUOUS AND MAXIMUM TOTAL CUTTING TIMES FOR VARIOUS TOOL TYPES IS INCLUDED IN THE MANUAL. 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 37 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. (B)(4).

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED FOR THE ATTACHMENT. THE DEVICE WAS TESTED AND THE MAXIMUM TEMPERATURE WAS MEASURED TO BE 120.0°F. HOWEVER THE RATE OF TEMPERATURE RISE WAS BELOW THRESHOLD AT 1.0°F/SEC. THE LIKELY CAUSE WAS IDENTIFIED AS THE DISTAL BEARING BEING WORN DUE TO INADEQUATE PREVENTIVE MAINTENANCE. IN ADDITION, IT WAS NOTED THAT THE OUTER RACE HAD BEEN SPLIT INTO TWO. THE USER MANUAL CONTAINS THE FOLLOWING ¿HEAVY SIDE LOADS AND/OR LONG OPERATING PERIODS MAY CAUSE THE DEVICE TO OVERHEAT. IF OVERHEATING OCCURS: NEVER PLACE AN OVERHEATED MOTOR ON THE PATIENT OR DRAPING DURING SURGERY. DISCONTINUE USE AND REST THE MOTOR BY USING INTERMITTENTLY, OR WRAP THE MOTOR/ATTACHMENT INTERFACE WITH A MOIST STERILE TOWEL. IF THE MOTOR IS PASSED OFF, THE RECEIVER SHOULD GRASP THE MOTOR BY THE PROXIMAL END CLOSE TO THE MOTOR HOSE. TO AVOID INJURY TO THE PATIENT OR USER, DO NOT PLACE THE HANDPIECE ON THE PATIENT OR IN AN UNSECURED LOCATION, WHEN NOT IN USE.¿ IN ADDITION, ¿CONTINUOUS CUTTING FOR EXTENDED PERIODS MAY CAUSE THE DEVICE TO HEAT TO AN UNCOMFORTABLE TEMPERATURE.¿ MAXIMUM CONTINUOUS AND MAXIMUM TOTAL CUTTING TIMES FOR VARIOUS TOOL TYPES IS INCLUDED IN THE MANUAL. 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 37 MONTHS WITH NO RECORD OF FACTORY SERVICE DURING THIS PERIOD. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. (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

    UPON FOLLOW UP, ATTEMPTS TO DETERMINE THE PATIENT CURRENT STATUS WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PHYSICIAN HAS OBSERVED AN OVERHEATING OF THE DRILL DURING THE DRILLING OF THE INNER EAR. THE OVERHEATING HAS DAMAGED THE FACIAL NERVE WHICH WAS IN CONTACT WITH THE LEGEND ATTACHMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572712 LEGEND ANGLED ATTACHMENT MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other