SYMPHONY

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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 DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, 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.

Description of Event or Problem

WHILE PERFORMING A POSTERIOR CERVICAL CASE, THE SURGEON AND SCRUB TECH WERE IN THE PROCESS OF CUTTING A ROD TO FIT INTO THE POLY SCREWS. THE SCRUB TECH WAS HOLDING BOTH ENDS OF THE ROD WITH A KOCHER AND ROD HOLDER WHEN USING THE SYMPHONY ROD HOLDER TO MAKE THE CUT ON THE ROD AND IT BROKE WITH A PIECE COMING OFF OF THE INSTRUMENT HITTING THE SCRUB TECH¿S FINGER CAUSING A SMALL CUT BY THEIR FINGER NAIL. THE SURGEON CONTINUED WITH THE CASE WHILE THE SCRUB TECH WENT DOWN TO THE ER TO HAVE HER FINGER EXAMINED. THIS DID NOT AFFECT THE PATIENT IN SURGERY AT THE TIME AND ONLY ADDED TWO TO THREE MINUTES TO THE CASE. AT THE ER, THEY CLEANED THE SCRUB TECH¿S WOUND AND BANDAGED IT WITHOUT NEEDING ANY STITCHES. THEY ALSO TOOK A SAMPLE OF BLOOD TO CHECK FOR ANY INFECTIOUS DISEASES. THE SCRUB TECH RETURNED TO THE OR WITHOUT ANY INCIDENCES. THERE HAS NOT BEEN ANY ISSUE WITH THEIR FINGER SINCE THEN THAT HAS BEEN REPORTED.

Additional Manufacturer Narrative

DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11. ADDITIONAL NARRATIVE: H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: LOT # PROVIDED IS NOT A VALID NUMBER, THEREFORE, THE DHR COULD NOT BE COMPLETED. IF DEVICE IS RETURNED OR LOT NUMBER CAN BE CONFIRMED, THE DHR WILL BE REVISITED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.