MITEK FMS ROUND BUR, 4.0 MM
Received Mar 1, 2010 · Event occurred Feb 16, 2010
Report 1221934-2010-00097 · MDR key 1621040
Device
Generic name
Arthroscopic Instrument
Manufacturer
Depuy MitekModel number
287750Catalog number
287750
Lot number
0427
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 THAT DURING ARTHROSCOPIC PROCEDURES THE SURGEON IS NOTING METAL SHAVINGS EMANATING FROM 5 MITEK FMS SHAVER BURS AND FALLING INTO THE JOINT SPACE. IT IS NOT KNOW IF ALL OF THE DEBRIS WAS ABLE TO BE REMOVED FROM THE BODY. HOWEVER, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE SURGEON IS NOT HAPPY WITH THE FMS PERFORMANCE AND IS NO LONGER USING FMS, BUT HAS RETURNED TO EBERLE BLADES WHICH HE CLAIMS DO NOT SHED METAL DEBRIS. ALSO SEE ASSOCIATED MDRS 1221934-2010-00093, 1221934-2010-00094, 1221934-2010-00095 AND 1221934-2010-00096.
Additional Manufacturer Narrative
MITEK IS AT THIS POINT IN TIME IN THE INFO 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.