MalfunctionHTT
3.0MM SMALL-JOINT HOODED ABRASION BUR, FORMULA 5B
Received May 6, 2009 · Event occurred Apr 7, 2009
Report 2648666-2009-00084 · MDR key 1436372
Device
Product problems
- Metal Shedding Debris
Patient
UNK
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT ALLEGEDLY THE SHAVER BLADE FLAKED METAL SHAVINGS INSIDE THE PATIENT DURING A KNEE SCOPE ARTHROSCOPY. ANOTHER ITEM FROM A DIFFERENT LOT WAS USED. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE SHAVINGS WERE SUCTIONED OUT OF THE PATIENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Remedial action
- Replace