AFFIXUS®
Received Jul 6, 2026 · Event occurred Jun 22, 2026
Report 25716634 · MDR key 25716634
Device
Patient
44 YR · Female
- Foreign Body In Patient
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
FROM OPERATIVE REPORT: LONG GUIDEWIRE WAS THEN PLACED FROM PROXIMAL TO DISTAL. AT THE LEVEL OF THE FRACTURE WE USED A BONE CLAMP TO IMPROVE OUR ALIGNMENT OVERALL. WE THEN ADVANCED THE GUIDEWIRE MORE DISTALLY TO ENSURE CENTER CENTERED POSITIONED. ONCE SATISFIED WITH THE POSITIONED BOTH THE GUIDEWIRE AND OUR FRACTURE REDUCTION, A LONG REAMER WAS PASSED OVER THE GUIDEWIRE FROM PROXIMAL TO DISTAL TRAVERSING THE FRACTURE SITE. AT THIS POINT AFTER PASSING THIS FIRST REAMER, IT WAS NOTED THAT THE REAMER HEAD HAD DISENGAGED FROM THE SHAFT. IT WAS STILL CONTROLLED BY THE GUIDEWIRE. THEY REAMER SHAFT WAS REMOVED AND THE REAMER HEAD WAS REMOVED BY EXTRACTING THE GUIDEWIRE. UNDER FLUOROSCOPY, IT WAS NOTED THAT THERE WERE SEVERAL METAL FRAGMENTS WITHIN THE TIBIAL CANAL. UPON INSPECTION OF THE REAMER HEAD ITSELF THERE WERE SEVERAL SMALL TABS THAT WERE BROKEN OFF. THIS WAS THE METAL CONTAINED WITHIN THE CANAL. GIVEN THE POSITIONED OF THESE FRAGMENTS IT WOULD REQUIRE SUBSTANTIAL DISSECTION OF SOFT TISSUE AND OPENING THE FRACTURE SITE. I FELT THAT THIS WAS TOO INVASIVE AND CHOSE TO LEAVE THE METAL FRAGMENTS IN PLACE, CONTAINED WITHIN THE INTRAMEDULLARY CANAL. WE THEN PLACED A SECOND LONG GUIDEWIRE AND, USING A DIFFERENT REAMING SYSTEM PREPARED THE CANAL UNTIL "GOOD CHATTER" WAS HEARD. WE THEN EXCHANGED THIS GUIDEWIRE FOR 1 COMPATIBLE WITH THE NAILING SYSTEM. THE TIBIAL NAIL WAS PLACED OVER THE LONG GUIDEWIRE AND ADVANCED FROM PROXIMAL TO DISTAL PASSING THE FRACTURE SITE UNTIL IT WAS WELL SEATED. POSITION WAS VERIFIED ON BOTH AP AND LATERAL VIEWS. FRACTURE APPEARED WELL-POSITIONED HARDWARE APPEARED WELL-POSITIONED ALSO.