AMERICAN EAGLE INSTRUMENTS

Additional Manufacturer Narrative

RECEIVED INSTRUMENT AND BROKEN TIP. A END TIP BROKE APPROXIMATELY 2.5 MM FROM END. VISUAL INSPECTION OF INSTRUMENT INDICATES THIS INSTRUMENT HAS BEEN WELL USED. TIP HAS DENTS, GOUGES, SCRATCHES, ETC. WORKING EDGE HAS BEEN WORN DOWN TO A RADIUS. THE COATING MATERIAL HAS BEEN REMOVED EXPOSING THE SUBSTRATE METAL. INSTRUMENT HAS A LOT CODE OF 1GP INDICATING IT WAS MANUFACTURED IN JULY OF 2011. MANUFACTURER RECOMMENDS A LIFE EXPECTANCY OF 6 MONTHS OF REGULAR USE FOR THESE INSTRUMENTS. WORKING THROUGH A DISTRIBUTER THIS ALLOW APPROXIMATELY 12-18 MONTHS FROM DATE OF MANUFACTURING. THIS INFORMATION IS PROVIDED FOR EACH INSTRUMENT AND AVAILABLE ON MANUFACTURER WEBSITE. THIS INSTRUMENT IS OVER 6 YEARS PAST LIFE EXPECTANCY. SINCE 2015, THERE HAVE BEEN (B)(4) PRODUCTS (AEGDP13-14XPX) SOLD. THERE HAVE ONLY BEEN 4 PRODUCT COMPLAINTS RELATING TO THIS PRODUCT. THAT CORRELATES TO A (B)(4) COMPLAINTS. THIS IS A VERY SMALL COMPLAINT PERCENTAGE AND INDICATES A USER ERROR RATHER THAN A MANUFACTURING DEFECT. THE TIP LIKELY BROKE DUE AGE AND EXCESSIVE FORCE.

Description of Event or Problem

CURETTE TIP BROKE OFF DURING ROOT CLEANING DISTOLINGUAL CORNER OF TOOTH 6- (1. MOLAR RIGHT LOWER JAW). DEEP POCKET 8 MM. TIP OF INSTRUMENT (~2.5 MM FROM END) BROKE OFF IN PATIENTS MOUTH DURING USE. THE PATIENT HAD TO UNDERGO SURGERY TO HAVE THE TIP REMOVED. THE TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PATIENT MADE A FULL RECOVERY.