AFFIXUS®

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT INSERTION OF AN INTRAMEDULLARY NAIL INTO THE LEFT TIBIA AND OPEN REDUCTION AND INTERNAL FIXATION OF THE LEFT FIBULA. DURING THE PROCEDURE, THE REAMER HEAD DISENGAGED FROM THE REAMER SHAFT WHILE REAMING THE TIBIAL CANAL. A LONG GUIDEWIRE WAS PLACED FROM PROXIMAL TO DISTAL. AT THE LEVEL OF THE FRACTURE, A BONE CLAMP WAS USED TO IMPROVE OVERALL ALIGNMENT, AND THE GUIDEWIRE WAS ADVANCED MORE DISTALLY TO ENSURE CENTER-CENTER POSITION. ONCE SATISFIED WITH THE GUIDEWIRE POSITION AND FRACTURE REDUCTION, A LONG REAMER WAS PASSED OVER THE GUIDEWIRE FROM PROXIMAL TO DISTAL, TRAVERSING THE FRACTURE SITE. AFTER PASSING THE FIRST REAMER, IT WAS NOTED THAT THE REAMER HEAD HAD DISENGAGED FROM THE SHAFT. THE REAMER HEAD WAS STILL CONTROLLED BY THE GUIDEWIRE. THE REAMER SHAFT AND HEAD WERE REMOVED BY EXTRACTING THE GUIDEWIRE. THE REPORTING REPRESENTATIVE STATED THAT THE SYSTEM USED A GUIDEWIRE AND THAT THE SURGICAL TECHNIQUE ADVISES AGAINST BENDING THE WIRE BY MORE THAN 10 DEGREES. THE REPRESENTATIVE REPORTED THAT THE SURGEON PLACED A MORE AGGRESSIVE BEND IN THE GUIDEWIRE, WHICH THE REPRESENTATIVE FLAGGED DURING THE CASE. THE REPRESENTATIVE DESCRIBED THE REAMER HEAD ADVANCING PAST THE BEND; ON WITHDRAWAL, THE HEAD REMAINED PAST THE BEND WHILE THE SHAFT RETRACTED, AND THE SHAFT CONTINUED RUNNING WHILE THE HEAD WAS DETACHED, CONTACTING THE HEAD AT THE CONNECTION INTERFACE, WHICH THE REPRESENTATIVE BELIEVES BROKE THE TABS OFF THE HEAD. NO DAMAGE TO THE REAMER SHAFT WAS REPORTED. UNDER FLUOROSCOPY, SEVERAL METAL FRAGMENTS WERE NOTED WITHIN THE TIBIAL CANAL. PER THE OPERATIVE REPORT, UPON INSPECTION OF THE REAMER HEAD, SEVERAL SMALL TABS WERE NOTED TO BE BROKEN OFF, CONSISTENT WITH THE METAL CONTAINED WITHIN THE CANAL. GIVEN THE POSITION OF THESE FRAGMENTS, RETRIEVAL WOULD HAVE REQUIRED SUBSTANTIAL SOFT TISSUE DISSECTION AND OPENING OF THE FRACTURE SITE, AND THE SURGEON ELECTED TO LEAVE THE METAL FRAGMENTS IN PLACE WITHIN THE INTRAMEDULLARY CANAL. A SECOND LONG GUIDEWIRE WAS PLACED AND, USING A DIFFERENT REAMING SYSTEM, THE CANAL WAS PREPARED UNTIL GOOD CHATTER WAS HEARD. THE GUIDEWIRE WAS EXCHANGED FOR ONE COMPATIBLE WITH THE NAILING SYSTEM. THE TIBIAL NAIL WAS PLACED OVER THE LONG GUIDEWIRE AND ADVANCED FROM PROXIMAL TO DISTAL ACROSS THE FRACTURE SITE UNTIL WELL SEATED. POSITION WAS VERIFIED ON AP AND LATERAL VIEWS. THE FRACTURE AND HARDWARE APPEARED WELL POSITIONED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4) D10: ASSOCIATED PRODUCT INFORMATION, PART (LOT): 211300400 (UNKNOWN),211300200 (67005262) 211300007 (67145188), 211306443 (67328962), 815409330 (67187259), 814650036 (67101264), 814650046 (67379168), 814650024 (67006849), 211300200 (67052285), 903003004 (UNKNOWN), 00-2490-075-43 (UNKNOWN), 770708121 (UNKNOWN), 770018160 (UNKNOWN), 770002200 (UNKNOWN), 770002250 (UNKNOWN), 770270016 (UNKNOWN), 770271016 (UNKNOWN), 770350010 (UNKNOWN), 770350012 (UNKNOWN). H6: PROPOSED ANNEX G CODE: MECHANICAL (G04) - DRILL. IT IS UNKNOWN WHETHER THE DEVICE WILL 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.