MalfunctionHTT
MITEK FMS CUTTER BLADE
Received Aug 4, 2010 · Event occurred Jul 15, 2010
Report 1221934-2010-00261 · MDR key 1791876
Device
Generic name
Barrell Tornado Burr Ultra Aggressive 5.5m
Manufacturer
Depuy MitekModel number
287885Catalog number
287885
Lot number
0814P
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 A SUB-ACROMIAL DECOMPRESSION PROCEDURE, THE SURGEON NOTED METAL FILINGS EMANATING FROM THE SHAVER BLADE AND FALLING INTO THE PATIENT¿S JOINT SPACE. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.
Additional Manufacturer Narrative
AT THIS POINT IN TIME, MITEK IS IN THE GATHERING INFORMATION MODE. IF AND WHEN MORE INFORMATION BECOMES AVAILABLE, THEN, MITEK WILL SUBMIT A FOLLOW-UP REPORT.