WIRE

Description of Event or Problem

AFTER A HEART PROCEDURE THE PATIENT WAS CLOSED WITH (2) WIRES IN THE MANUBRIUM, (3) STERNAL ZIPFIX WITH NEEDLE ON THE STERNUM, AND A WIRE AT THE ZYPHOID. ON A FOLLOW-UP SCAN THE STERNUM HAD "SHIFTED UP". REPORTEDLY THE STERNUM HAS HEALED IN AN IMPROPER POSITION. THE SURGEON HAS NO PLANS TO RE-OPEN THE PATIENT AT THIS TIME. THIS REPORT IS #6 OF 6 FOR THE SAME EVENT.

Additional Manufacturer Narrative

INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.