MITEK FMS 4.0 MM BARREL TORNADO BUR
Received May 1, 2008 · Event occurred Apr 21, 2008
Report 1221934-2008-00246 · MDR key 1037422
Device
Generic name
Arthroscopic Instrument
Manufacturer
Depuy MitekModel number
287780Catalog number
287780
Lot number
0524
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
Additional Manufacturer Narrative
WE ARE AT THIS POINT IN TIME, AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A FAILURE ANALYSIS. WE ARE ALSO IN THE INFO GATHERING MODE. "WHEN ALL THAT CAN BE HAD, IS HAD AND EVALUATED, THE RESULTS OF THE INVESTIGATION WILL BE THE SUBJECT OF THE FOLLOW-UP REPORT."
Description of Event or Problem
OUR AFFILIATE IS REPORTING THAT DURING A SHOULDER REPAIR, THE SURGEON NOTED THAT THERE WERE METAL FILINGS EMANATING FROM THE SHAVER AND FALLING INTO THE PT'S JOINT SPACE. THIS IS ALL OF THE INFO THAT HAS BEEN SUPPLIED TO MITEK BY OUR AFFILIATE. "HAVE ANY QUESTIONS TO THEM OUR FOR FURTHER DETAILS."