BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE, M4 ROTATABLE RAD 60

    MDR report key: 1842655 · Received September 1, 2010

    Report

    Report Number
    1045254-2010-00044
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED FROM THE REPORTER. 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. RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THE PT IS REPORTED TO BE IN GOOD CONDITION WITH NO ADVERSE SEQUELA AS A RESULT OF THIS EVENT. ALL PORTIONS OF THE BROKEN BUR WERE RETURNED, INDICATING THAT NO DEVICE FRAGMENTS WERE LEFT IN THE PT. VISUAL INSPECTION FOUND NO DAMAGE TO THE TEETH OF THE INNER OR THE OUTER BLADE AND NO DAMAGE TO THE INNER OR OUTER HUBS. VISUAL AND DIMENSIONAL INSPECTION SHOWED THAT THE MIDDLE TUBE FRACTURE AT THE FIRST LOOP OF THE DOVETAIL SPIRAL WRAP CAUSING APPROX 1/2 INCH PORTION OF THE TIP TO BECOME DETACHED. THE "DOVETAIL SPIRAL WRAP" IS THE TOP, CURVED PORTION OF THE MIDDLE TUBE WHERE IT IS DESIGNED TO ALLOW A CURVED TUBE THAT CAN ROTATE. FUNCTIONAL INSPECTION SHOWED THAT THE BLADE WOULD LOAD PROPERLY INTO THE HANDPIECE. IFU STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: 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. THIS IS THE FIRST REPORT OF THIS TYPE ON THIS BLADE LOT. WHILE IT IS NOT COMMON FOR A POWERED BUR/BLADE TO BREAK, OUR DATA SHOWS THAT ON RARE OCCASION, A SERIOUS INJURY (SI) OR SURGICAL INTERVENTION HAS OCCURRED DUE TO A BREAK RESULTING IN A DEVICE FRAGMENT. MOST BLADE FRAGMENTS ARE EASILY REMOVED FROM THE PT WITHOUT ADD'L INTERVENTION OR DIRECT HARM AND ALLOW THE SURGICAL PROCEDURE TO PROCEED AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    DURING SINUS SURGERY, THE BLADE TIP BROKE. THE SURGEON RECOVERED THE PORTION OF THE BLADE FROM THE SINUS WHICH DID NOT RESULT IN A DELAY IN SURGERY. THE BLADE TIP WAS EASILY REMOVED WITHOUT THE USE OF ADD'L EQUIPMENT OR SURGICAL PROCEDURE AND THE ORIGINAL PROCEDURE PROCEEDED AS INTENDED. THERE WAS NO ADVERSE PT SEQUEL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE, M4 ROTATABLE RAD 60 77EQJ EQJ MEDTRONIC XOMED, INC. 1884016HR 65190400

    Patients

    Seq Age Sex Outcome Treatment
    1 NI