BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG

    MDR report key: 2093806 · Received May 18, 2011

    Report

    Report Number
    1045254-2011-00035
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    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

    THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THIS DEVICE WAS OUT OF SPECIFICATION IN AN AS RECEIVED CONDITION. BECAUSE OF THE CONDITION OF THE RETURNED DEVICE, NO CONCLUSION CAN BE DRAWN. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT PROBLEM HAS CAUSED ADVERSE EVENTS IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. WITHOUT INTERVENTION, OR SERIOUS INJURY, THIS REPORT IS BEING FILED AS PRODUCT PROBLEM.

    Description of Event or Problem · 1

    DESCRIPTION OF THE ORIGINAL COMPLAINT: SINUS BUR BROKE DURING SURGERY WITH NO SERIOUS INJURY. RELEVANT EVENTS AND INFORMATION OBTAINED FOR THE REPORTED INCIDENT: JUST PRIOR TO THE INCIDENT, THE SURGEON WAS PERFORMING LOTHROP SINUS SURGERY. WHILE DRILLING IN THE FRONTAL SINUS, THE DEVICE IN QUESTION BROKE AND THE PORTION THAT BECAME DETACHED WAS REMOVED FROM THE PATIENT. SUBSEQUENT ACTIONS PERTINENT TO THIS EVENT: THE FACILITY STATES "CONTINUED DRILLING OF THE FRONTAL SINUSES AFTER REMOVING AND REPLACING THE BROKEN SINUS BUR." THE SURGERY PROCEEDED AS INTENDED WITH A DELAY OF APPROXIMATELY 30 MINUTES. THERE WAS NO ADVERSE PATIENT CONSEQUENCES OR SEQUELA REPORTED. NO ADDITIONAL FOLLOW-UP CARE OR PROCEDURES WERE REQUIRED AS A RESULT OF THIS PRODUCT PROBLEM. THE INNER TUBE WAS DAMAGED (BENT) WITH GOUGES AROUND THE OUTSIDE DIAMETER BETWEEN 1.5 TO 2.5 INCHES AWAY FROM THE FACE OF THE HUB INDICATING THAT THE DAMAGE OCCURRED BEFORE USE. BOTH THE INNER AND OUTER SPIRAL WRAP BROKE APPROXIMATELY 3 7/8 INCH FROM THE FACE OF THE HUB CORRESPONDING TO THE OUTER TUBE BEND AREA. THE REMAINING PIECE, CONSISTING OF THE TIP AND A PORTION OF THE SPIRAL WRAP MEASURED 1 7/8 INCH. TORSION DAMAGE INDICATES THAT THE BUR BROKE WHILE IN USE AND RUNNING IN THE FORWARD DIRECTION. JUST BEHIND THE BUR HEAD, THE OUTER SPIRAL WRAP WAS BENT AND THE INNER WAS PULLED APART BUT STILL INTACT. ALL PORTIONS OF THE BUR WERE RECEIVED INDICATING THAT THERE WERE NO UNRETRIEVED DEVICE FRAGMENTS. THERE WAS DEFORMATION OF THE LOCKING AREA WITH SOME GOUGING AND FLARING OF THE DISTAL END OF THE OUTER TUBE. THE END OF THE OUTER TUBE WALL THICKNESS MEASURED FROM .011 TO .008 INCH. THIS DAMAGE INDICATES EXCESSIVE PRESSURE WAS APPLIED DURING USE. THE DISTAL END OF THE OUTER TUBE HAD A CHAMFER ON THE INSIDE DIAMETER CORRESPONDING TO THE REVERSE TAPER ON THE PROXIMAL SIDE OF THE BUR HEAD. THERE WAS DAMAGE TO ALL 4 CHEVRONS CAUSED BY A MISALIGNMENT OF THE HANDPIECE DRIVE MECHANISM AND DIMPLES ON THE OUTER HUB PRIOR TO THE LOCKING AREA CAUSED BY THE HANDPIECE LOCKING MECHANISM. THIS DAMAGE INDICATES IMPROPER LOADING. IFU STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: DISCONTINUE POWERED APPLICATION IN THE EVENT OF LACK OF VISUALIZATION OF THE SURGICAL SITE. ALWAYS INSPECT THE COMPONENTS BEFORE AND AFTER USE FOR ANY DAMAGE. IF DAMAGE IS OBSERVED, DO NOT USE DAMAGED PART UNTIL IT IS REPLACED. DAMAGED PARTS MAY DEPOSIT METAL SHAVINGS ON SURGICAL SITE. EXCESSIVE PRESSURE APPLIED TO BUR MAY CAUSE BUR FRACTURE. SHOULD A BUR FRACTURE OCCUR DURING USE, EXTREME CARE MUST BE EXERCISED TO ENSURE THAT ALL FRAGMENTS OF THE BUR ARE RETRIEVED AND REMOVED FROM THE PATIENT. UNREMOVED BUR FRAGMENTS MAY CAUSE TISSUE DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG EQJ MEDTRONIC XOMED INC. 1883672HS 71025600

    Patients

    Seq Age Sex Outcome Treatment
    1