STERNUM BLADE (100PK) OFFSET (32.0 X 0.79 X 6.3MM)

Additional Manufacturer Narrative

ADVERSE EVENT PROBLEM: THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT AVAILABLE FOR RETURN.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE OFF IN THE STERNUM BONE. THE PROCEDURE WAS STOPPED, THE PATIENT¿S LUNGS WERE RE-INFLATED, THE PRODUCT WAS REMOVED, AND A NEW PRODUCT WAS OBTAINED TO FINISH PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; THE DURATION OF THE SURGICAL DELAY WAS NOT REPORTED, AND NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED.