THE TIP OF A HU-FRIEDY BARNHART CURETTE BROKE IN A PT'S MOUTH DURING A PROCEDURE FOR SCALING AND ROOT PLANING FOR THE MAXILLARY RIGHT POSTERIOR SEXTANT AND LOCAL DELIVERY OF A CHEMOTHERAPEUTIC AGENT FOR AILING IMPLANT #3. THE BROKEN TIP WAS NOT VISIBLE ON X-RAYS TAKEN AT THE DOCTOR'S OFFICE. THE DOCTOR ADVISED THE PT TO PROCEED TO THE HOSPITAL FOR EMERGENCY TREATMENT. THE PT WAS ADMITTED TO THE HOSPITAL AND REFERRED TO AN ENT FOR A SCOPING PROCEDURE. IT WAS REPORTED THAT THE TIP WAS VISUALIZED RADIOGRAPHICALLY IN THE LARYNX AND THAT THE INTUBATION PROCESS MAY HAVE PUSHED THE INSTRUMENT TIP DOWN INTO THE ESOPHAGUS. WHILE STILL HOSPITALIZED, THE PT SUFFERED FROM A CARDIAC EVENT. THE PT WAS SENT TO A SECONDARY FACILITY WHERE A CARDIAC CATHETERIZATION, ANGIOPLASTY AND INSERTION OF A CARDIAC STENT WAS ORDERED. THE DENTIST OFFICE IS UNABLE TO CONFIRM IF THE PT RECEIVED ALL OF THE RECOMMENDED PROCEDURES. THE DENTAL OFFICE IS ABLE TO CONFIRM THAT THE PT WAS RELEASED AND AT HOME BY (B)(6) 2015. NO FURTHER MEDICAL PROCEDURES OR THERAPIES WERE REPORTED.
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Patient 1
THE PRACTICE HAS NOT RETURNED THE BROKEN INSTRUMENT FOR HU-FRIEDY TO EVALUATE. WEIGHT OF THE PT IS NOT KNOWN. HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER UDI, ONLY A LOT WHICH IS TIED TO THE DATE OF THE MFR. THE PRODUCT INVOLVED IN THE EVENT DOES NOT HAVE AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. THE (A) NDA, IND, BLA, AND 510(K) ARE NOT APPLICABLE TO THIS CLASS I DEVICE.