MalfunctionHTT
5.5MM 12 FLUTE BARREL BUR- HOLLOW, FORMULA (5BX)
Received Sep 8, 2010 · Event occurred Aug 25, 2010
Report 2648666-2010-00388 · MDR key 1841242
Device
Product problems
- Flaked
- Metal Shedding Debris
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE ON THE SHOULDER, METAL FLAKES WERE COMING OFF THE UNIT. IT WAS FURTHER REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AND A DELAY OF 5-10 MINUTES OCCURRED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.