STERNUM BLADE
Received Jan 15, 2014 · Event occurred Dec 16, 2013
Report 0001811755-2014-00148 · MDR key 3575712
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-irelandCatalog number
0298097100
Lot number
UNKNOWN
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE STERNUM BLADE AND THE STERNUM BLADE GUARD BROKE. IT WAS ALSO REPORTED THAT THE FRAGMENTS WERE REMOVED FROM THE PATIENT¿S BODY. IT WAS FURTHER REPORTED THAT THERE WAS A TEN MINUTE SURGICAL DELAY; X-RAYS WERE TAKEN TO ENSURE NO FRAGMENTS WERE LEFT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE SAGITTAL HANDPIECE SAW AND A SAGITTAL BLADE.
Additional Manufacturer Narrative
DEVICE EVALUATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE STERNUM BLADE AND THE STERNUM BLADE GUARD BROKE. IT WAS ALSO REPORTED THAT THE FRAGMENTS WERE REMOVED FROM THE PATIENT¿S BODY. IT WAS FURTHER REPORTED THAT THERE WAS A TEN MINUTE SURGICAL DELAY; X-RAYS WERE TAKEN TO ENSURE NO FRAGMENTS WERE LEFT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE SAGITTAL HANDPIECE SAW AND A SAGITTAL BLADE.
Additional Manufacturer Narrative
THE DEVICE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.