MalfunctionHTT
4.0MM 12 FLUTE BARREL BUR - HOLLOW, FORMULA (5BX)
Received Feb 3, 2009 · Event occurred Dec 5, 2008
Report 2648666-2009-00019 · MDR key 1362408
Device
Product problems
- Metal Shedding Debris
- Improper or Incorrect Procedure or Method
Patient
UNK
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem
IT WAS REPORTED BY THE SALES REP THAT DURING BASIC KNEE SURGERY, SHAVINGS OF THE PRODUCT FLAKED INTO PT'S BODY. HE STATED THAT FROM WORKING WITH THE SURGEON IN THE PAST, HE MIGHT HAVE BEEN PUTTING HIS WEIGHT INTO IT CAUSING THE METAL PART TO HIT THE HOOD, THUS THE SHAVINGS OF THE INNER PORTION OF THE BUR, ENDED UP INSIDE OF THE PT. ANOTHER ITEM WAS USED AND THE CASE WAS COMPLETED SUCCESSFULLY. HE ALSO REPORTED THAT THE SURGEON WAS ABLE TO REMOVE MOST OF THE FLAKING OF THE BUR USING A GRASPER.
Remedial action
- Replace