STERNUM BLADE
Received Dec 9, 2013 · Event occurred Sep 18, 2013
Report 0001811755-2013-03153 · MDR key 3505706
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Stryker Instruments-kalamazooCatalog number
0298097100
Lot number
13182017
Product problems
- Break
- Fracture
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE PERFORMED AND A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AN ANATOMICAL DEFECT WAS NOTED WHEN THE SAW HIT A "KNOTTY" AREA THAT TORQUED GUIDES, THIS LEAD TO THE BLADE RUNNING OFF TRACK AND SUBSEQUENTLY BROKE. IT WAS ALSO REPORTED THAT ALL PIECES WERE RECOVERED. IT WAS FURTHER REPORTED THAT NO INJURY OCCURRED TO PATIENT OR STAFF.
Additional Manufacturer Narrative
IF THE BLADE IS RETURNED, AN EVALUATION WILL BE PERFORMED AND A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT YET RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AN ANATOMICAL DEFECT WAS NOTED WHEN THE SAW HIT A "KNOTTY" AREA THAT TORQUED GUIDES, THIS LEAD TO THE BLADE RUNNING OFF TRACK AND SUBSEQUENTLY BROKE. IT WAS ALSO REPORTED THAT ALL PIECES WERE RECOVERED. IT WAS FURTHER REPORTED THAT NO INJURY OCCURRED TO PATIENT OR STAFF.