CORAIL

Description of Event or Problem

IT WAS REPORTED THAT DURING THA IT WAS NOTED THAT THERE WAS AN ISSUE WITH THE SIZE 9 CORAIL BROACH. THE MALE ATTACHMENT OF THE BROACH HAD BEEN DEFORMED AND IT WAS EXTREMELY DIFFICULT TO LOAD THE BROACH ONTO A BROACH HANDLE, A NECK AND THE CALCAR PLANNAR. ALL THE OTHER BROACHES WORKED WITHOUT ISSUE. THERE WAS NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WERE NO PATIENT CONSEQUENCES.

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. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.