CANNULATED DRILL CS 6.5, D4, 4, L220, HUDSON
Received Jan 21, 2013
Report 8043862-2013-00002 · MDR key 2962074
Device
Product problems
- Break
- Difficult to Remove
- Difficult to Advance
Patient
54 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
GUIDE WIRES WERE PLACED FOR THE 6.5 STAINLESS SCREWS FOR THE SUBTALAR JOINT. SURGEON HAD PLACED TWO GUIDE WIRES THAT CROSSED EACH OTHER THRU THE JOINT. SURGEON WENT TO DRILL OVER THE K-WIRES AND AS HE STARTED TO ADVANCE THE DRILL BIT IT IMPLODED WHILE INSIDE THE BONE. SURGEON HAD ONLY DRILLED FOR ABOUT 2-3 SECONDS WHEN THIS HAPPENED. HE WAS NOT ABLE TO ADVANCE THE DRILL BIT VERY FAR BEFORE IT FELL APART. HE THINKS IT MAY HAVE HIT THE OTHER GUIDE WIRE. HE THEN PULLED THE DRILL BIT OUT AND BEGAN TO RECOVER THE DRILL BIT FRAGMENTS. HE WAS UNABLE TO GET ALL OF IT AND SOME OF THE DRILL BIT WAS LEFT INSIDE THE PATIENT. HE PROCEEDED TO IMPLANT THE SCREW AND HE DID HAVE A CHALLENGE GETTING THE SCREW TO ADVANCE BUT DID GET THE SCREW IMPLANTED. PLEASE ISSUE RMA AND I CAN SEND THE BROKEN DRILL BIT AND FRAGMENTS IN TO BE LOOKED AT.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RECEIVED TODAY FOR EVALUATION. INTEGRA LIFE SCIENCE HAS REPORTED AN MDR FORM 3500A (3004608878-2012-00233) AS MANUFACTURER ALTHOUGH AAP IMPLANTATE (B)(4) IS THE LEGAL MANUFACTURER.