MINIKIN

Description of Event or Problem

ON 1/17 THE CUSTOMER STATED THAT THE L511 PIN DRIVER BROKE IN THE PATIENT'S MOUTH. THE CUSTOMER STATED THAT THE PATIENT WAS NOT HURT. THE CUSTOMER THEN PROVIDED AN ASSESSMENT FORM WHERE THEY STATED THAT THEY WERE PUTTING THE MINIKIN CHANNELER INTO THE MAX PREMOLAR TOOTH WHEN METAL OF CHANNELER BROKE INTO TOOTH. THE PRACTITIONER THEN STATED THAT THEY LEFT THE CHANNELER IN THE TOOTH AND USED A SECOND CHANNELER TO PLACE A PIN IN A SECOND AREA OF THE SAME PREMOLAR. PER THE CUSTOMER, THE DRILL WAS LEFT IN THE PATIENT'S TOOTH TO ACT AS THE "PIN" AGAINST THE DRILLS INDICATIONS. THEREFORE, OUT OF AN ABUNDANCE OF CAUTION AND PER 21 CFR 803, THIS EVENT WILL BE REPORTED TO THE FDA.