MITEK FMS ROUND BUR, 4.0 MM
Received Jan 29, 2010 · Event occurred Jan 19, 2010
Report 1221934-2010-00039 · MDR key 1593127
Device
Generic name
Blade & Burrs
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 AN ARTHROSCOPIC PROCEDURE, THE SURGEON OBSERVED METAL FILINGS EMANATING FROM 2 SHAVER BLADES AND FALLING INTO THE PT'S JOINT SPACE. THE SURGEON STATES THAT IT WAS VERY DIFFICULT TO ASSEMBLE THE BLADES ONTO THE SHAVER MECHANISM FOR USE. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. SEE ALSO ASSOCIATED MDR 1221934-2010-00040.
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.