MalfunctionHTT
3.0MM SMALL-JOINT HOODED ABRASION BUR, FORMULA (5B)
Received Jan 17, 2008 · Event occurred Dec 24, 2007
Report 2648666-2008-00004 · MDR key 982888
Device
Product problems
- Flaked
Patient
UNK
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED VIA THE SALES REPRESENTATIVE THAT DURING AN ANKLE ARTHRODESIS PROCEDURE, THE TIP OF THE BUR BEGAN TO FLAKE AND METAL SHARDS WERE VISIBLE. IT IS FURTHER REPORTED THAT THE FUSED WOUND WAS FLUSHED AT THE END OF THE PROCEDURE.
Additional Manufacturer Narrative
DEVICE WILL NOT BE RETURNED TO MANUFACTURER. ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.