SIGMA

Description of Event or Problem

IN THE END SURGERY, THEY TRIED TO INSTALL THE INSERT AND IT DIDN'T GRASP ON THE TRAY AFTER SEVERAL ATTEMPTS. THEY TOOK A NEW INSERT AND ACHIEVED THE SAME RESULT. THEN THEY TOOK A SLIGHTLY HIGHER 1 MM BECAUSE THEY DIDN¿T HAVE MORE IN STOCK. THE SAME RESULT WAS ACHIEVED. THEY STRUGGLED WITH THE FOURTH INSERT AND THEY GOT IT IN PLACE.

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. ADDITIONAL NARRATIVE: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.