BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1884075HSE 15CM X 4MM 15DEG CUTTING

    MDR report key: 3718756 · Received April 1, 2014

    Report

    Report Number
    1045254-2014-00074
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    February 20, 2014
    Report Date
    March 4, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: (1) IGS M4 MICRODEBRIDER (1898200T); SN: (B)(4); LOT: 61805000; MANUFACTURED: MAY 6, 2009. (B)(4). IN RESPONSE TO MEDTRONIC'S REQUEST FOR DEVICE RETURN, THE DEVICE WAS RECEIVED AND IS CURRENTLY PENDING EVALUATION. THE DEVICE WAS RETURNED, EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. METHOD: NO TESTING METHODS PERFORMED. RESULTS: RESULTS PENDING COMPLETION OF EVALUATION.

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, BOTH PRODUCTS WERE RETURNED FOR EVALUATION¿HOWEVER EACH WAS EVALUATED SEPARATELY AT TWO (2) SEPARATE MEDTRONIC LOCATIONS, THE INTERNATIONAL AND US SITE (DETAILED AS FOLLOWS): (B)(4) (QUANTITY 1) ¿ THE PRODUCT WAS RETURNED WITH THE ORIGINAL OPENED PRODUCT BOX/LABEL AND THERE WAS EVIDENCE OF CUSTOMER USE BASED ON THE DEVICE BEING FOUND BROKEN. THE INNER SHAFT WAS BROKEN CLOSE TO THE HUB ASSEMBLY...THE OTHER BROKEN PIECE OF THE INNER SHAFT REMAINED INSIDE THE OUTER TUBE ASSEMBLY, AND COULD NOT BE REMOVED SINCE THE OUTER SHAFT WAS ANGLED/CURVED. THE BUR TIP REMAINED INTACT ON THE INNER SHAFT AND DID NOT DETACH/SEPARATE. THE BREAKAGE POINT SHOWED DISCOLORATION, POSSIBLY INDICATING AGGRESSIVE USE OF THE DEVICE BY THE CUSTOMER. THE HUB ASSEMBLY HAD NO VISIBLE DIMPLES ON THE HUB, WHICH WOULD INDICATE IMPROPER CUSTOMER LOADING OF THE DEVICE INSIDE THE HANDPIECE. (B)(4) (QUANTITY 1) ¿ ANALYSIS WAS NOT ABLE TO CONFIRM OR DUPLICATE THE ALLEGED COMPLAINT, FINDING NO FAULT OR OUT OF SPECIFICATION CONDITIONS DIRECTLY RELATED TO THE REPORTED EVENT. HOWEVER, THE DEVICE WAS RECEIVED BADLY CORRODED AND REQUIRED A NEW SHELL, MOTOR/CABLE ASSEMBLY, SEALS, BEARINGS, SPACERS AND GEARS, WHICH WERE ALL REPLACED. THE DEVICE WAS TESTED, PASSING ALL MANUFACTURER SPECIFICATIONS. (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

    IT WAS REPORTED INTRAOPERATIVELY THAT "WHILST DRILLING BONE" WITH A 15 DEGREE HIGH SPEED CUTTING BUR AND M4 MICRODEBRIDER, THE BUR STOPPED "WORKING/SPINNING". UPON INSPECTION, IT WAS DISCOVERED THAT THE SHAFT OF THE BUR HAD SNAPPED OFF AT THE PROXIMAL END INSIDE THE M4 MICRODEBRIDER. IT WAS CONFIRMED THAT THERE WERE NO FRAGMENTS, IT WAS A CLEAN BREAK AND THE FACILITY WAS ABLE TO GET THE BROKEN PIECE OF THE BUR OUT OF THE M4 MICRODEBRIDER. BOTH PIECES OF THE BUR WERE SENT TO THE MANUFACTURER FOR EVALUATION; HOWEVER THE M4 MICRODEBRIDER WAS RE-STERILIZED AND PUT BACK INTO USE WITH NO ISSUES. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED AS A RESULT OF THIS EVENT. NOTE: BREAKS IN HIGH SPEED BURS HAVE CAUSED DEVICE HEAT UP IN THE PAST AND HAS THE POTENTIAL TO REACH TEMPERATURES THAT MAY LEAD TO A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195201 BUR 1884075HSE 15CM X 4MM 15DEG CUTTING BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884075HSE 0207349611

    Patients

    Seq Age Sex Outcome Treatment
    1