SAGITTAL BLADE-STERNUM REVISION
Received Oct 19, 2015 · Event occurred Sep 23, 2015
Report 0001811755-2015-03843 · MDR key 5159508
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
2108137000
Lot number
UNKNOWN
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE IS NOT AVAILABLE FOR EVALUATION
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS FURTHER REPORTED THERE WAS A DELAY OF LESS THAN 30 MINUTES TO OBTAIN A REPLACEMENT BLADE AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Additional Manufacturer Narrative
THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS FURTHER REPORTED THERE WAS A DELAY OF LESS THAN 30 MINUTES TO OBTAIN A REPLACEMENT BLADE AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.