HTUBE IMPLANT KIT 2.75MM 0DEG CAN STRL

Additional Manufacturer Narrative

(B)(4). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING IMPLANTATION OF AN IMPLANT INTO A RIGHT 2ND TOE, THE IMPLANT BROKE AT THE MIDPOINT WHILE INSERTING THE PROXIMAL END. THE PROXIMAL END OF THE BROKEN IMPLANT WAS RETAINED IN THE PATIENT'S PROXIMAL PHALANX. THE PROCEDURE WAS COMPLETED BY UTILIZING A DIFFERENT DEVICE. THE IMPLANT WAS DIFFICULT TO INSERT AND THE PATIENT HAD HARD BONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.