BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRICUT BLADE 4MM

    MDR report key: 1669217 · Received April 21, 2010

    Report

    Report Number
    1045254-2010-00018
    Event Type
    Other
    Date Received
    April 21, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 22, 2010
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFO NOT BEING PROVIDED OR RELEASED BY THE REPORTER, DESPITE MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFO. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. A VISUAL INSPECTION SHOWED THE TIP OF THE INNER BLADE TUBE BROKE OFF AT THE VALLEY BETWEEN THE FIRST AND SECOND PROXIMAL TOOTH. THE RETURNED TIP FRAGMENT MEASURED 6.2 MM BY 3.8 MM, AND WHEN COMPARED TO THE BREAK POINT UNDER A MICROSCOPE, NO PORTIONS WERE MISSING INDICATING NO FRAGMENT WAS LEFT IN THE PT. THE OUTER BLADE TUBE DIAMETER WAS PUSHED OUT ON THE RIGHT SIDE INDICATING THAT THE INNER BLADE CAUGHT ON THE OUTER BLADE CAUSING THE BREAKAGE. INSPECTION OF THE INNER BLADE HUB SHOWED DAMAGE IN THE FORM OF DIMPLES AND GOUGES AROUND THE CIRCUMFERENCE OF THE HUB PROXIMAL TO THE PROPER LOCKING LOCATION. THIS DAMAGE INDICATES THAT THE BLADE WAS NOT FULLY SEATED AND WAS IMPROPERLY LOADED INTO THE HAND PIECE BY THE USER. FUNCTIONAL TESTS WITH A POWERED HANDPIECE SHOWED THE BLADE WOULD FULLY SEAT AND LOCK INTO PLACE AS DESIGNED. THE INSTRUCTIONS FOR USE INCLUDES, BUT IS NOT LIMITED TO THE FOLLOWING: EXCESSIVE PRESSURE APPLIED TO BLADE MAY CAUSE BUR FRACTURE. SHOULD A BLADE FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BLADE ARE RETRIEVED AND REMOVED FROM THE PT. UNREMOVED BLADE FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PT. BLADE OR BUR INSTALLATION: USING THUMB, DEPRESS THE LOCKING COLLAR (A) ON THE FRONT OF THE HANDPIECE. INSERT BLADE OR BUR WITH A SLIGHT ROTATING MOTION UNTIL BLADE OR BUR IS SEATED. ALIGN BLADE OR BUR TIP OPENING TO DESIRED POSITION. RELEASE THE LOCKING COLLAR. PULL ON THE BLADE OR BUR TO ENSURE ENGAGEMENT AND VISUALLY CHECK TO MAKE SURE DISTAL TIP OF INNER BLADE IS IN CONTACT WITH THE DISTAL TIP OF THE OUTER CANNULA. ALWAYS INSPECT THE COMPONENTS BEFORE AND AFTER USE FOR ANY DAMAGE. IF DAMAGE IS OBSERVED, DO NOT USE DAMAGED PART UNTIL IT IS REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TIP BROKE OFF INTO THE PT DURING SINUS SURGERY, BUT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRICUT BLADE 4MM 77 EQJ EQJ MEDTRONIC XOMED, INC. 1884004 H7536514

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention