COUPLER

Additional Manufacturer Narrative

INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PINS OF A 2.0MM COUPLER WAS NOT ALIGNED. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H10: THE DEVICE WAS RECEIVED FOR EVALUATION. SIGNS OF USE (DRIED BLOOD AND TISSUE) WERE VISIBLE ON THE RETURNED COUPLER RINGS WHICH IS CONSISTENT WITH THE REPORTED ALLEGED EVENT TAKING PLACE DURING USE. A VISUAL INSPECTION WAS DONE WHICH OBSERVED A MISALIGNMENT IN THE RINGS. THE MISALIGNMENT VISIBLE IN THE RETURNED RINGS WOULD NOT ALLOW FOR THE PROCESS TO BE COMPLETED SUCCESSFULLY WITH THE RINGS IN THE ORIENTATION IN WHICH THEY WERE BROUGHT TOGETHER (APPROXIMATED). THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, IF EITHER COUPLER RING HAD BEEN PARTIALLY DISLODGED FROM THE JAW ASSEMBLY DURING PREPARATION FOR OR DURING THE SURGICAL PROCESS, A MISALIGNMENT OF THE COUPLER RINGS IS POSSIBLE. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.