Description of Event or Problem · 0
ON 27 APRIL 2026, THE MANUFACTURER WAS INFORMED BY ITS U.S. DISTRIBUTOR (B)(4) OF AN EVENT INVOLVING A OSTEOTEC SILICONE FINGER IMPLANT. THE DISTRIBUTOR REPORTED THAT THE IMPLANT WAS OBSERVED TO BE TORN/BROKEN UPON REMOVAL DURING A REVISION SURGERY. THE INITIAL IMPLANTATION PROCEDURE WAS PERFORMED ON (B)(6) 2026. AFTER THE REVISION PROCEDURE ON 07 APRIL 2026, IT WAS REPORTED THAT ONE EDGE OF THE IMPLANT WAS BROKEN OFF; HOWEVER, BOTH PIECES OF THE DEVICE WERE SUCCESSFULLY REMOVED. THE REASON FOR THE REVISION SURGERY WAS NOT PROVIDED, AND THE CAUSE OF THE REPORTED DEVICE BREAKAGE IS UNKNOWN. THE DISTRIBUTOR INDICATED THAT THE PATIENT WAS BELIEVED TO BE COMPLIANT WITH POST-OPERATIVE PROTOCOLS. NO ADDITIONAL PATIENT COMPLICATIONS OR ADVERSE OUTCOMES WERE REPORTED. THE IMPLANT SIZE AND LOT NUMBER HAVE NOT YET BEEN CONFIRMED BUT IS BELIEVED TO BE EITHER SIZE OSTF-1 OR OSTF-00 - TO BE CONFIRMED UPON DEVICE RETURN. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. NO PHOTOGRAPHS OR PHYSICAL EVIDENCE HAVE BEEN PROVIDED TO DATE. THE MANUFACTURER HAS INITIATED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. INVESTIGATION IS ONGOING.