Description of Event or Problem · 0
REMOVAL OF A MEDICAL DEVICE IMPLANTED SCREW FROM ARTHREX ENDED UP BREAKING OFF AT THE FOURTH THREAD DOWN ON THE SHAFT UNDER THE HEAD IN MY RIGHT FOOT UPON REMOVAL ON (B)(6) 2024 DURING SURGERY AND DOCTOR DECIDED LEAVE IT IN THE BONE. NO ETCHED PART# TO IDENTIFY SCREWS. ON (B)(6) 2024 I HAD TWO PLATES AND EIGHT SCREWS SURGICALLY INSTALLED FOR A LISFRANC FRACTURE AND AM CURRENTLY HEALING. I HAVE PHYSICALLY HAVE ALL PRODUCT THAT WAS INSTALLED IN RIGHT FOOT. HAVE CONTACTED ARTHREX AND HAVE GIVEN THEM INFORMATION TO A (B)(4) WHO IS A PRODUCT SURVEILLANCE SPECIALIST 2 WHO STARTED A COMPLAINT CASE (B)(4) FOR WHAT PART NUMBERS AND LOT NUMBERS WERE USED IN SURGERY FROM DR. (B)(6) OF THE (B)(6). HERE ARE THOSE PART NUMBERS: PART# AR-L8935CL-26, LOT# 15078868 (KREULOCK SCREW), PART# AR-8935-22, LOT# 15110232 (LOPRO SCREW), PART# AR-8935CL-32, LOT# 15049045 (KREULOCK SCREW), PART# AR-8951MR LOT# 5262328 (LISFRANTIC PLATE), PART# AR-8943-42, LOT# 031127 (DRILL BIT), PART# 13226T, LOT# 21468-09 ( DB-TAK). HERE ARE THE FACTS AT THIS TIME. AR-8935CL-32, LOT# 15049045, WAS THE ONLY SCREW I COULD NOT MEASURE TO THE 32MM LENGTH BECAUSE OF IT BEING BROKEN OFF INSIDE MY BONE. ARTHREX GAVE ME THESE MEASUREMENTS IN THEIR TABLE BELOW: I HAVE THE 22MM SCREWS AND 26MM SCREWS MEASURED RESPECTIVELY. THEREFORE, I BELIEVE THE 7MM BROKEN ITEM I HAVE PHYSICALLY IS THE ADVERSE EVENT PART AND LOT NUMBER RECORDED IN THE OPENING STATEMENT ABOVE. I AM ALSO SENDING YOU ATTACHMENTS OF THE X-RAYS BEFORE AND AFTER SURGERY. ARTHREX DID LET ME KNOW THAT NONE OF THESE SCREWS WERE ON A MARKET WITHDRAWAL OR RECALL WHEN ASKED. PART NUMBER: AR-8935CL-32; MEASUREMENT: 3.5 MM X 32 MM.