STLESS STEEL SIL 4X18IN 6 S/A V-40

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE STRAIGHT PACKET WITH THREE NEEDLE SUTURE COMBINATIONS, ONE SUTURE AND ONE DETACHED NEEDLE WAS RECEIVED FOR ANALYSIS. THE PRODUCT CODE M649G IS MULTI-STRANDS AND CONTAINS FOUR STRAND PER PACKET. UPON VISUAL ASSESSMENT OF THE NEEDLES, NO ISSUES RELATED TO BREAKAGE NEEDLE WERE OBSERVED. HOWEVER, AN INCORRECT SWAGE WAS FOUND IN ONE NEEDLE, SINCE THE SWAGE MARK WAS LIGHT. THIS CAUSED THAT THE SUTURE WAS DETACHED OF THE NEEDLE. IN ADDITION, THE NEEDLES WERE TESTED BY RESISTANCE TEST AND MET THE REQUIREMENTS. BASED ON THE INFORMATION CURRENTLY AVAILABLE, AN INCORRECT SWAGE ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: DID THE NEEDLE PIECE FALL INTO THE PATIENT? UNK IF YES, WAS THE NEEDLE PIECE(S) RETRIEVED DURING THE SAME PROCEDURE? WERE X-RAYS TAKEN TO LOCATE THE NEEDLE PIECE(S)? WHAT MEASURES WERE TAKEN TO RETRIEVE THE BROKEN PIECE? IF NOT RETRIEVED, IN WHAT TISSUE STRUCTURE THE BROKEN NEEDLE WAS RETAINED? IS THERE ANY PLAN IN PLACE TO REMOVE THE NEEDLE PIECE IN THE FUTURE? PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (E.G. NURSE, SURGEON, RISK MANAGER) JJKK QA STAFF, (B)(6). PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. THE DEVICE HAS BEEN RECEIVED AT SUKAGAWA AND WILL BE SHIPPED. PLEASE CHECK RMAO. TRACKING NUMBER: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. AFFILIATE REFERENCE NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.