NO PRODUCT FAULT COULD BE DETECTED. WE FOUND THAT THE WIRE IS BROKEN AT THE THREADED PART ABOUT 4MM BELOW THE BALL. THE THREAD FLANKS AT THE BROKEN FRAGMENT ARE BADLY DAMAGED, BUT AFTERWARDS IT CAN NOT BE DEFINED IF THIS DAMAGE WAS CAUSED DURING THE INSERTION OR DURING THE EXTRACTION OF THE FRAGMENT. THE EXACT CAUSE OF THIS OCCURRENCE CAN NOT BE DEFINED. BASED ON THE APPEARANCE OF THE FRACTURE FACE AND THE STRESS MARKS AT THE WIRE ABOVE THE BALL WE CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD CAUSED THIS BREAKAGE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
D
Patient 1
PATIENT WAS UNDERGOING A PROCEDURE ON THE 3RD METATARSAL. THE SURGEON USED A COMPRESSION WIRE PER THE SURGICAL TECHNICAL PERPENDICULAR TO A 3 HOLD PLATE. HE DRILLED THROUGH THE FIRST CORTEX AND AS IT PENETRATED THE SECOND CORTEX TO APPLY COMPRESSION THE WIRE BROKE AT THE JUNCTION BELOW THE OLIVE. THE SURGEON HAD TO SPLIT THE METATARSAL TO REMOVE THE WIRE AS IT WAS PROTRUDING TOO MUCH THROUGH THE SECOND CORTEX TO LEAVE IT IN. THE PROCEDURE WAS EXTENDED ABOUT 45 MINUTES AND WAS COMPLETED SUCCESSFULLY.
N
Patient 1
INVESTIGATION IS ONGOING. DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION. NO CONCLUSION CAN BE DRAWN.