MalfunctionHTT
2.0MM SMALL-JOINT HOODED ABRASION BUR, FORMULA (5B
Received May 9, 2011 · Event occurred Mar 29, 2011
Report 2648666-2011-00130 · MDR key 2133224
Device
Product problems
- Break
- Detachment Of Device Component
- Sticking
- Metal Shedding Debris
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE END OF THE INNER CANNULA BROKE OFF. IT WAS FURTHER REPORTED THAT THE BURR UNIT WILL NOT ENGAGE OR ROTATE. FURTHER, THE ACCOUNT REPORTS THEY EXPERIENCED A SIMILAR FAILURE WITH A SECOND UNIT. FURTHER, METAL FLAKES WERE NOTED IN THE JOINT AFTER USING THE BURR UNITS.
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.