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Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO THE MFR ON DECEMBER 14, 2007 AND NOT ON 12/05/07 AS INDICATED IN DISTRIBUTOR REPORT. INSTRUMENT WAS RETURNED COMPLETE WITH ALL FOUR BLADES AND SCREWS THAT ARE DESIGNED TO SECURELY HOLD THE BLADES IN PLACE, BUT TO ALSO KEEP THEM MOVABLE FOR THEIR INDICATED USE. IT WAS THOROUGHLY CHECKED BY GENERAL MANAGER AND SENIOR SURGICAL INSTRUMENT ENGINEER. A TOTAL OF NINE (9) INSTRUMENTS WERE MANUFACTURED WITH PRODUCTION LOT # 07/07 IN JULY 2007 AND DELIVERED TO THE DIST. PRODUCTION OF THIS ARTICLE BEGAN IN JUNE 2002. THIS IS THE SECOND TIME THAT AN INCIDENT WITH THIS RETRACTOR DESIGN WAS REPORTED IN OVER FIVE (5) YRS AND THE SECOND IN THREE MOS AT THE SAME HOSP. A RENEWED REVIEW OF OUR PROD DOCUMENTS DETERMINED THAT THE INSTRUMENT WAS MANUFACTURED IN ACCORDANCE WITH THE CUSTOMER'S DESIGN AND THE MFG PRODUCTION AND QC SPECS. AGAIN, AS WITH THE PREVIOUS INCIDENT, VISUAL INSPECTION REVEALED THAT THE SCREWS WITH WHICH THE BLADES ARE FASTENED TO THE RETRACTOR FRAME, HAD BEEN MANIPULATED AT THE USER SITE. THESE SCREWS ARE NOT INTENDED TO BE REMOVED FOR BLADE POSITIONING OR FOR CLEANING AND STERILIZATION. AS FOR THE INSTRUMENT AND ITS PARTS, NO NONCONFORMANCES COULD BE DETECTED. ACCORDING TO THE DIST INFO REC'D, THE HOSP GAVE ASSURANCES THAT THE BLADES WERE NEVER REMOVED OR THE SCREWS UNTIGHTENED. CONSIDERING THE FACT THAT OF CLOSE TO 500 INSTRUMENTS IN FIVE YEARS, ONLY TWO INCIDENTS OCCURRED AT THE SAME HOSP IN LESS THAN THREE MOS, THIS IS HARD TO BELIEVE. CONCLUSION: SINCE NONCONFORMANCES IN DESIGN OR MFG COULD BE EXCLUDED, THE ONLY POSSIBLE CAUSE FOR THIS DEVICE FAILURE MAY ORIGINATE IN THE HOSPITAL'S DEVICE PROCESSING. CAPA: NEVERTHELESS, TO PREVENT FUTURE OCCURRENCES OF THIS TYPE, THE FOLLOWING CORRECTIVE ACTION WAS IMPLEMENTED IMMEDIATELY AFTER THE FIRST INCIDENT REPORT WAS REC'D IN OCTOBER, 2007. AS OF THAT MO, ALL SCREWS FOR THIS RETRACTOR DESIGN ARE ADDITIONALLY FASTENED WITH SCREW LOCKING ADHESIVE LOCTITE 243. THIS FDA-CLEARED ADHESIVE WILL PREVENT SCREWS FROM ALL LOTS MANUFACTURED AFTER THAT DATE FROM LOOSENING, WHETHER BY INTENTION OR ACCIDENTALLY. THIS CAPA ACTION SHOULD ALSO PREVENT FUTURE INCIDENTS IN CLINICAL APPLICATION OCCURRING WITH THIS RETRACTOR MODEL.