HU-FRIEDY 5-68 BARNHART CURETTE, RESINEIGHT

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 MANUFACTURE. 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.

Description of Event or Problem

CURETTE WITH A RESIN HANDLE BROKE OFF AT SHANK PRIOR TO SCALING PROCEDURES, WHILE DOING SOME EXPLORING WITHIN THE MOUTH. AN AMBULANCE WAS CALLED AND THE PT WAS TRANSPORTED TO THE LOCAL HOSPITAL AND WENT TO THE EMERGENCY ROOM. THE BROKEN TIP WAS REMOVED FROM THE GI TRACT BY A ENDOSCOPIC PROCEDURE. PT IS DOING FINE, NO ADDITIONAL MEDICAL PROCEDURES OR TREATMENT NEEDED.