MalfunctionDWH
STERNUM BLADE
Received Feb 13, 2012 · Event occurred Dec 27, 2012
Report 9616696-2012-00031 · MDR key 2460900
Device
Product problems
- Break
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MFR FOR EVAL. LOT NUMBER INFO HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.
Description of Event or Problem
IT WAS REPORTED VIA THE REPAIR UNIT IN (B)(6) THAT THE BROKEN BLADE WAS RECEIVED IN ADDITION TO OTHER DEVICES FROM THE ACCOUNT. IT IS UNK IF THERE WAS ANY PT INVOLVEMENT OF ADVERSE CONSEQUENCES AS A RESULT OF THE BROKEN BLADE. NO FURTHER INFO WAS PROVIDED.