BROKEN INFORMATION RECEIVED FROM MEDWATCH FORM (B)(4):? DURING PROCEDURE, THE TIP OF THE MICRO GRAY CAREFUSION V. MUELLER NERVE HOOK BROKE OFF DURING USE.? THE MISSING PORTION WAS ESTIMATED AT ABOUT 1MM IN LENGTH.? THE SURGEON SEARCHED THE WOUND AND AN INTRAOPERATIVE X-RAY WAS TAKEN.? THE X-RAY WAS READ AS NEGATIVE FOR FOREIGN BODY IDENTIFIED.? THE NERVE HOOK WAS TAKEN OUT OF USE.? ADDITIONAL INFORMATION OBTAINED ON (B)(6)2012 AFTER SPEAKING WITH THE CUSTOMER (RISK MANAGER).? THE INSTRUMENT NUMBER AND LOT NUMBER WERE PROVIDED.? THE INSTRUMENT CANNOT BE RETURNED TO CAREFUSION.? HOWEVER, A CAREFUSION REPRESENTATIVE MAY VISIT THE SITE TO SEE THE INSTRUMENT IF AN AGREEMENT IS SIGNED.? IN ADDITION, PICTURES OF THE INSTRUMENT WILL BE PROVIDED ONCE THE AGREEMENT HAS BEEN SIGNED.
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Patient 1
(B)(4), CUSTOMER IS NOT WILLING TO SEND DEVICE TO CAREFUSION FOR EVALUATION. THEY MIGHT BE WILLING TO SEND PHOTO'S. IF PHOTOS ARE MADE AVAILABLE, WE WILL DO AN EVALUATION BASED ON THE PHOTO'S AND A FOLLOW UP WILL BE SENT.
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Patient 1
(B)(4): NO INSTRUMENT OR PICTURES WERE SUPPLIED TO AID THE INVESTIGATION. THE PRODUCT AND LOT CODE WERE REPORTED AS BEING (B)(4) MANUFACTURED IN FEBRUARY 2007. THIS WOULD MEAN THE INSTRUMENT WAS OVER 5 YEARS OLD. THE INFORMATION SUPPLIED FROM THE USER, IS THAT APPROXIMATELY 1MM OF THE TIP BROKE OFF, IT IS UNKNOWN IF THE 1MM WAS FROM THE OVERALL LENGTH OR ONLY THE TIP (THE TIP OF THE INSTRUMENT NOTED IS APPROXIMATELY 2MM AFTER A 90 DEGREE BEND). THE CONDITION OF THE INSTRUMENT PRIOR TO THE INCIDENT REPORTED IS UNKNOWN. IT IS ALSO UNKNOWN IF THE INSTRUMENT HAD BEEN MODIFIED PRIOR TO THIS INCIDENT. IN THE PAST YEAR, THERE HAVE BEEN NO REJECTIONS OR DEVIATIONS RELATED TO THE INSTRUMENT BREAKING DURING THE MANUFACTURE OF THIS PRODUCT. THIS IS THE ONLY COMPLAINT ON RECORD FOR THIS PRODUCT CODE IN MORE THAN 5 YEARS.