STERNAL CRIMPER

Additional Manufacturer Narrative

QN#(B)(4). THE DEVICE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER HOWEVER THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Additional Manufacturer Narrative

(B)(4). DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE NOTED COMPLAINT RESULTED IN A CHANGE OF SUPPLIER AND INCREASED INSPECTION REQUIREMENTS IN AUGUST OF 2009. (2) SAMPLES OF 342004 LOT XX8 (DEC 2008) WERE RECEIVED FOR THE SAME ISSUE. BOTH SAMPLES WILL BE INVESTIGATED TOGETHER. NO VISUAL CONCERNS WERE NOTED. THE DEVICES WERE FUNCTIONALLY EVALUATED TO OBSERVE THE LEAF SPRING RUBBING ON THE ATTACHMENT SCREW. THIS FRICTION PREVENTS FREE MOVEMENT OF THE JAWS TO RETURN TO A FULLY OPEN POSITION. THE JAWS MAY STILL BE USED WITH A LIGHT PULLING FORCE ON THE HANDLES. THE DEVICE IS STILL FUNCTIONAL AS-IS. NO FURTHER INVESTIGATION IS REQUIRED. THIS ISSUE WAS PREVIOUSLY INVESTIGATED AND CORRECTED IN AUGUST OF 2009. A PREVIOUS INCIDENT RESULTED IN A CHANGE OF SUPPLIER AND INCREASED INSPECTION REQUIREMENTS. THERE HAVE BEEN NO INSTANCES SINCE THE CORRECTIVE ACTION WAS IMPLEMENTED. THE CUSTOMER WILL BE ISSUED REPLACEMENTS.

Description of Event or Problem

ALLEGED EVENT: THE CRIMPER DOES NOT OPEN COMPLETELY WHICH INHIBITS THE CLIPS FROM BEING USED TO SECURE THE STERNUM. FOUND DURING PRODUCT DEMONSTRATION. THERE WAS NO PATIENT INVOLVEMENT.

Description of Event or Problem

ALLEGED EVENT: THE CRIMPER DOES NOT OPEN COMPLETELY WHICH INHIBITS THE CLIPS FROM BEING USED TO SECURE THE STERNUM. FOUND DURING PRODUCT DEMONSTRATION. THERE WAS NO PATIENT INVOLVEMENT.