MITEK FMS BARREL TORNADO BUR
Received Sep 25, 2009 · Event occurred Sep 9, 2009
Report 1221934-2009-00370 · MDR key 1509432
Device
Generic name
Arthroscopic Instrument
Manufacturer
Depuy MitekModel number
287885Catalog number
287885
Lot number
0806H
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
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.
Description of Event or Problem
OUR AFFILIATE IS REPORTING THAT DURING AN ARTHROSCOPIC PROCEDURE, METAL SHAVINGS EMANATED FROM THE FMS BUR/SHAVER BLADE AND WAS NOTICED (MOST LIKELY SCATTERINGS ON FILM) DURING AN MRI OF THE PATIENT'S JOINT SPACE. ALTHOUGH THE DEBRIS WAS NOT REMOVED FORM THE BODY, THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT.