FMA BARREL BUR, 4.0MM
Received Apr 25, 2008 · Event occurred Apr 9, 2008
Report 1221934-2008-00211 · MDR key 1034944
Device
Generic name
Surgical Instrument
Manufacturer
Depuy MitekModel number
287760Catalog number
287760
Lot number
7520F0648
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 SHAVINGS EMANATING FROM THE SHAVER. THIS IS ALL OF THE INFO THAT HAS AT THIS POINT IN TIME BEEN GIVEN TO MITEK, QUESTIONS OUT TO OUR AFFILIATE FOR CLARITY AND FURTHER INFO.
Additional Manufacturer Narrative
AT THIS POINT IN TIME, MITEK IS IN THE INFO GATHERING MODE, AND IS AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING ROOT CAUSE FAILURE ANALYSIS. WHEN ALL OF THIS IS DONE, THE RESULTS OF THE INVESTIGATION WILL BE THE SUBJECT OF THE FOLLOW-UP REPORT.