UNK TIBIAL KEEL PUNCH/BULLET

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, 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.

Description of Event or Problem

IT WAS REPORTED THE ATTUNE TIBIA DRILL TOWER MOVED BACK AND FORTH DURING THE DRILLING. IT WAS REPORTED THE EVALUATION BULLET IN QUESTION AND THE INSERT TRIAL WERE ROTATED, AND THE TIBIAL TRAY CENTER AND THE INSERT TRIAL CENTER DID NOT MATCH. NO SURGICAL DELAY.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # ==> PC-(B)(4).UPON FURTHER REVIEW, IT HAS BEEN DETERMINED THAT THERE IS NO ALLEGATION AGAINST THE DEVICE, NO REPORTABLE EVENT. FURTHER UPDATES WILL ONLY BE PROVIDED IF ADDITIONAL INFORMATION IS RECEIVED THAT CHANGES THE REGULATORY DETERMINATION.