InjuryHTT
MITEK FMS TORNADO BARREL BURR
Received Dec 1, 2009 · Event occurred Nov 23, 2009
Report 1221934-2009-00493 · MDR key 1550267
Device
Generic name
Arthroscopic Instrument
Manufacturer
Depuy MitekModel number
287785Catalog number
287785
Lot number
0818E
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNK
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
OUR AFFILIATE REPORTS THAT DURING AN ANKLE SCOPE PROCEDURE, THE SURGEON NOTED METAL FILINGS IN THE BODY WITH THE USE OF AN FMS TORNADO BARREL BURR. AT THIS POINT, THE SURGEON CHOSE TO GO OPEN TO FLUSH OUT THE DEBRIS. QUESTIONS OUT FOR FURTHER DETAIL.
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.