HU-FRIEDY #2 MOLT SINGLE END CURETTE

Additional Manufacturer Narrative

WEIGHT OF PT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE THE INFO. HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT # WHICH IS TIED TO THE DATE OF MFR. THE PRODUCT INVOLVED IN THE EVENT WAS A STAINLESS STEEL INSTRUMENT THAT DOES NOT HAVE A EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. RETURNED TIP IS BROKEN APPROX 11.4 MM FROM THE TIP. BROKEN TIP WAS INCLUDED. RETURNED INSTRUMENT IS OLD AND WORN. THE BROKEN TIP IS DAMAGED. IT IS DULL, CHIPPED, AND HAS GOUGES AT THE BACK OF THE WORKING END. THE REMAINING UNBROKEN SECTION (SHANK) IS BENT AND DOES NOT MATCH CURRENT PRODUCT. CONCLUSION: BREAKAGE APPEARS TO HAVE BEEN THE RESULT OF APPLYING A FORCE HIGHER THAN MATERIAL CAPABILITY TO THE WORKING END. THESE TYPES OF INSTRUMENTS (CM2) HAVE A NORMAL LIFE EXPECTANCY OF UP TO 4 YEARS. THE RETURNED INSTRUMENT WAS MFG ALMOST 26 YEARS AGO (1985).

Description of Event or Problem

THE CURETTE WAS BEING USED TO EXTRACT A MAXILLARY MOLAR. THE END OF CURETTE FRACTURED WHILE REMOVING THE REMAINING DISTAL ROOT TIP. THE TIP FELL INTO THE MAXILLARY SINUS CAVITY THROUGH THE ORAL ANTRAL OPENING THAT WAS CREATED BY THE EXTRACTION.