MalfunctionHTT
FMS BARREL BUR, 4.0MM
Received Dec 14, 2009 · Event occurred Nov 27, 2009
Report 1221934-2009-00497 · MDR key 1584600
Device
Generic name
Arthroscopic Instrument
Manufacturer
Depuy MitekModel number
287760Catalog number
287760
Lot number
0816
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 NOTED METAL SHAVINGS EMANATING FROM THE DEVICE AND FALLING INTO THE PT'S JOINT SPACE. THIS IS ALL OF THE INFO THAT WE HAVE SO FAR... THERE ARE QUESTIONS OUT TO OUR AFFILIATE TOWARDS CLARITY.
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.