MITEK FMS BARREL BUR, 4.0 MM
Received Dec 22, 2009
Report 1221934-2009-00523 · MDR key 1581101
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 SHOULDER PROCEDURE, THE SURGEON NOTED METAL SHAVINGS EMANATING FROM THE DEVICE AND FALLING INTO THE PT'S JOINT SPACE. THE FACILITY REPORTS THAT THIS PHENOMENON HAS HAPPENED IN 5 OTHER CASES WITH DEVICES FROM SAME LOT; FACILITY UNABLE TO FURNISH DATES FOR THESE. HOWEVER, THEY REPORT THAT IN THESE 6 PROCEDURES, ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURES WERE CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. SEE ALSO ASSOCIATED MDRS 1221934-2009-00497, 1221934-2009-00519, 1221934-2009-00520, 1221934-2009-00521 AND 1221934-2009-00522.
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 F/U REPORT.