MITEK FMS 5.5MM BARREL TORNADO BURR
Received May 1, 2008 · Event occurred Apr 18, 2008
Report 1221934-2008-00242 · MDR key 1037415
Device
Generic name
Arthroscopic Instrument
Manufacturer
Depuy MitekModel number
287880Catalog number
287880
Lot number
0433
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 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 QUESTIONS TO THEM OUT FOR FURTHER DETAILS."
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."