MalfunctionHTT
5.5MM 6 FLUTE UNHOODED BARREL BUR, FORMULA (5BX)
Received Mar 3, 2010 · Event occurred Mar 9, 2010
Report 2648666-2010-00149 · MDR key 1644529
Device
Product problems
- Flaked
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER HAD METAL FLAKING IN 4 OF THEIR LAST 5 SHOULDER PROCEDURES. ALLEGEDLY, THE SHAVER ALMOST APPEARS TO STUTTER OR SKIP. IT WAS FURTHER REPORTED THAT DIFFERENT HANDPIECES, FOOTPEDALS AND TPS CONSOLES WERE USED AND THE METAL IS STILL BEING SEEN.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.