IDEAL

Additional Manufacturer Narrative

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 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: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED, AND NO CONCLUSION CAN BE DRAWN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY, THE IDEAL SUTURE SHUTTLE 45 DEGREES LEFT RING WAS BROKE OFF AND THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.