HENRY SCHEIN

Additional Manufacturer Narrative

THE INSTRUMENT TIP WAS BROKEN AT THE TERMINAL SHANK. THE MICROHARDNESS AND MICROSTRUCTURE EVALUATED AT THE TIP WAS NORMAL. THE BROKEN SURFACE REVEALED EXCESSIVE CORROSION CONSISTENT WITH STRESS CORROSION CRACKING. THIS DENTAL EXPLORER REVEALED NO SIMILARITIES TO INSTRUMENTS THAT WERE WITHIN THE RECALLED LOTS (Z-0526/Z0529-5) THAT CONTAINED ABOVE SPECIFICATION HARDNESS VALUES AND IRREGULAR MICROSTRUCTURES. THESE TYPES OF EXPLORERS WITH REGULAR RE-USE HAVE A LIFE EXPECTANCY OF 2 YEARS. THE DATE CODE PRINTED ON THE INSTRUMENT INDICATED THAT THIS INSTRUMENT WAS ALMOST 4 YEARS OLD AT THE TIME OF BREAKAGE. THE PROBABLE CAUSE OF BREAKAGE IS RELATED TO THE CORROSION THAT OCCURRED OVER A PERIOD OF TIME AND THE USE OF THE INSTRUMENT IN THAT IT HAD EXCEEDED ITS USEFUL LIFE. THE DENTAL OFFICE HAD BEEN NOTIFIED ON THREE OCCASIONS ABOUT THE ONGOING RECALL (Z-0526/0529-5), TWICE BY MAIL AND ONCE BY PHONE. THE OFFICE HAD PURCHASED A TOTAL OF 23 INSTRUMENTS SUSPECTED TO BE WITHIN THE SUSPECT DATE RANGE. A TOTAL OF 20 INSTRUMENTS WERE RETURNED BY THIS DENTAL OFFICE DURING THE COURSE OF THE RECALL.

Description of Event or Problem

INSTRUMENT TIP BROKE AND PATIENT RECEIVED SMALL CUT ON THE LIP FROM BROKEN TIP. THE TIP WAS RETRIEVED AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION.