BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED DIAMOND DCR BUR,2.5MM,HI-SPD 3/BX

    MDR report key: 2151773 · Received July 6, 2011

    Report

    Report Number
    1045254-2011-00049
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE. THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THIS DEVICE WAS OUT OF SPECIFICATION IN AN AS RECEIVED CONDITION. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. WITHOUT SERIOUS INJURY WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM.

    Description of Event or Problem · 1

    DESCRIPTION OF THE ORIGINAL COMPLAINT: "DURING PROCEDURE, THE TIP BROKE." NO PATIENT IMPACT. RELEVANT EVENTS AND INFORMATION OBTAINED FOR THE REPORTED INCIDENT: JUST PRIOR TO THE INCIDENT THE SURGEON WAS DOING ENDOSCOPIC SINUS SURGERY. WHILE USING THE DEVICE IN QUESTION, A PORTION OF THE BUR BECAME DETACHED IN THE SURGICAL SITE. SUBSEQUENT ACTIONS PERTINENT TO THIS EVENT: THE FACILITY STATES THAT THE FRAGMENT WAS EASILY REMOVED. A SECOND DEVICE WAS USED AND THE SURGERY PROCEEDED AS INTENDED WITHOUT ANY SIGNIFICANT DELAY OR ADDITIONAL PROCEDURES. THERE WAS NO ADVERSE PATIENT CONSEQUENCES OR SEQUELA REPORTED. NO ADDITIONAL FOLLOW-UP CARE WAS REQUIRED AS A RESULT OF THIS EVENT. VISUAL INSPECTION SHOWED A WEAR MARK OCCURRING 5/8 INCHES AWAY FROM THE INNER HUB WITH STRIATIONS EMANATING APPROXIMATELY ONE TENTH OF AN INCH AWAY FROM THE WEAR MARK. THE DAMAGE CORRESPONDS TO THE BEGINNING OF THE OUTER TUBE INSIDE THE OUTER TUBE HUB. DEFORMATION IN THE FORM OF INDENTATIONS WAS FOUND IN THE LOCKING AREA AND WAS CAUSED BY THE HANDPIECE LOCKING MECHANISM. THE DISTAL END OF THE OUTER TUBE WAS BLOWN OUTWARD AT THE SUPPORT POINT FOR THE INNER TUBE. CORRESPONDING GOUGING WAS FOUND ON THE INNER TUBE SUPPORT AREA JUST BEHIND THE TIP. THE DAMAGE TO THE INNER TUBE, OUTER TUBE, LOCKING AREA, AND OUTER HUB WAS REPRODUCED BY APPLYING EXCESSIVE PRESSURE DURING USE. THE INNER TUBE BROKE AT THE END OF THE SPIRAL WRAP, 5/8 INCH FROM THE END OF BUR TIP. DIMPLES WERE PRESENT ON THE OUTER HUB PRIOR TO THE LOCKING AREA CAUSED BY THE HANDPIECE LOCKING MECHANISM AND THE TIPS OF THE INNER HUB CHEVRONS WERE DAMAGED. THIS DAMAGE IS INDICATIVE OF IMPROPER INSTALLATION AND WAS REPRODUCED BY IMPROPERLY LOADING A KNOWN GOOD BUR CAUSING THE OUTER HUB DAMAGE. ACTIVATING THE HANDPIECE REPRODUCED THE CHEVRON DAMAGE. FUNCTIONAL INSPECTION SHOWED THAT THE BUR LOADS PROPERLY INTO THE HANDPIECE. IFU STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO: 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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED DIAMOND DCR BUR,2.5MM,HI-SPD 3/BX BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1882569HS NI

    Patients

    Seq Age Sex Outcome Treatment
    1