MITEK FMS BARREL TORNADO BURR, 4.0MM
Received Jun 29, 2010 · Event occurred Jun 1, 2010
Report 1221934-2010-00228 · MDR key 1743977
Device
Generic name
Arthroscopic Instrument
Manufacturer
Depuy MitekModel number
287785Catalog number
287785
Lot number
0923P/Q11
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR THE SURGEON NOTED THAT THERE WERE METAL SHAVING EMANATING FROM THE FMS TORNADO BURR AND FALLING INTO THE PATIENT'S JOINT SPACE. THEY WERE NOT ABLE TO REMOVE ALL OF THE DEBRIS; THE PATIENT WILL BE MONITORED BECAUSE OF THIS. HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE SURGEON STATES THAT HE DID NOT PUT ANY UNDO FORCES ONTO THE DEVICE WHILST IT WAS IN USE.
Additional Manufacturer Narrative
MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.