MalfunctionFEC
BLUNT OBTURATOR, 3.5MM
Received Aug 28, 2007
Report 2028292-2007-00008 · MDR key 905367
Device
Product problems
- Metal Shedding Debris
Patient
YR
- Foreign body, removal of
Narrative
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, HOWEVER, THE EVAL IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION FINDINGS. THIS IS THE FIRST REPORT OF THIS FAILURE MODE FOR THIS DEVICE.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THIS OBTURATOR IN A WRIST ARTHROSCOPY PROCEDURE, METAL SHAVINGS WERE OBSERVED IN THE JOINT. THE SURGEON FLUSHED THE SHAVINGS, HOWEVER, IT IS UNK IF ALL METAL SHAVINGS WERE REMOVED FROM THE JOINT. THERE WAS NO REPORT OF PT INJURY WITH THIS EVENT.