HENRY SCHEIN MAXIMA DISTAL END CUTTER

Additional Manufacturer Narrative

DEVICE WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY FILE REVIEW COULD NOT BE COMPLETED AS NO LOT NUMBER WAS PROVIDED FOR THE DEVICE. WITH NO DEVICE IN HAND, ROOT CAUSE ANALYSIS OF THE ISSUE IS LIMITED. COMPLAINT AND RETURN HISTORY WERE REVIEWED FOR THE DEVICE.

Description of Event or Problem

A PIECE OF THE WORKING END OF THE DEVICE BROKE INSIDE THE PATIENT'S MOUTH DURING AN ORTHO PROCEDURE. THEY WERE SENT TO ER AND IMAGING FOUND THE PIECE IN THEIR INTESTINE. PATIENT WAS SCHEDULED FOR FOLLOW UP IN TWO WEEKS TO HAVE IT REMOVED. THE PIECE WAS LATER DISCHARGED FROM THE BODY AND NO SURGICAL INTERVENTION WAS REQUIRED.