4.5MM VA-LCP CURVED CONDYLAR PLATE/14HOLE/301MM/LT-STER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN RECEIVED; THE PREVIOUSLY REPORTED EVENT IS NO LONGER CONSIDERED REPORTABLE AT THIS TIME AS THERE WAS NO FAILURE OF THE DEVICE. NO FURTHER FOLLOW-UPS WILL BE SENT.

Description of Event or Problem

REPORT RECEIVED FROM THE SWEDISH MEDICAL PRODUCTS AGENCY. IT WAS REPORTED THAT THREE SEPARATE INCIDENTS OF PLATES OF THE SAME TYPE HAVE UNEXPECTEDLY BROKEN POST OPERATIVELY BEFORE THE PATIENT¿S FRACTURE HAS HEALED. THERE IS NO APPARENT EXTERNAL CAUSE SUCH AS SLOW HEALING OR HEAVY PATIENT. THE THIRD CASE WE DO NOT HAVE AN ID FOR. THE PLATE ITSELF WAS RECENTLY INTRODUCED TO US. THE CONSEQUENCE FOR THE PATIENT WAS A REOPERATION WITH A NEW PLATE. (B)(4): EVENT 1. (B)(4): EVENT 2. (B)(4): EVENT 3.

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 MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.