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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: 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 AN UNSPECIFIED SURGERY, THE IMAGE OF THE DEVICE REMAINED BLURRY EVEN WHEN FOCUSING. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. AFTER SURGERY, WHEN WIPING THE COUPLER, BLACK OIL WAS FOUND ON THE LENS. ALTHOUGH CLEANING AND STERILIZING ACCORDING TO THE INSTRUCTIONS, THE COUPLER LENS GETS HEAVILY SOILED. THE SALES REP HAVE ALSO RECEIVED FEEDBACK SUGGESTING THAT GREASE MIGHT BE MELTING FROM THE SCREW CONNECTION TO THE CAMERA HEAD. AFTER CLEANING THE OIL FILM, THE IMAGE WAS CLEAR AND WORKED WITHOUT PROBLEMS. NO FURTHER INFORMATION WAS AVAILABLE.