5/6 BARNHART CURETTE, USC/SUTER
Received Jul 26, 2023
Report 1416605-2023-00005 · MDR key 17398933
Device
Product problems
- Break
- Break
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A DENTAL PROCEDURE A PIECE OF ONE OF THE TIPS TO THEIR 5/6 BARNHART CURETTE, USC/SUTER DETACHED IN THE PATIENT'S MOUTH. THE PART WAS SURGICALLY REMOVED.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO HU-FRIEDY FOR EVALUATION WITHOUT THE DETACHED PIECE AND THE FRACTURED SURFACE ON THE BROKEN TIP SHOWED SIGNS OF OVERLOAD FAILURE. ADDITIONALLY, THE RETURNED DEVICE HAD RESIDUE, CORROSION, AND SCRATCHES. THE DEVICE HAS TWO TIPS AND THE OTHER UNBROKEN TIP SHOWED SIGNS OF DULLNESS. THIS DULLNESS WOULD CAUSE ADDITIONAL FORCE TO BE REQUIRED TO USE THE DEVICE AND COULD RESULT IN THE REPORTED FAILURE. AS THE DETACHED PIECE WAS NOT RETURNED, WE ARE UNABLE TO CONFIRM IF IT SHOWED SIGNS OF DULLNESS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SUBJECT OF THE REPORTED EVENT WAS REVIEWED AND NO ABNORMALITIES WERE NOTED. A 12 MONTH COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. THE HU-FRIEDY INSTRUMENT REPROCESSING GUIDE STATES "3.2 INSPECTION INSPECT ALL INSTRUMENTS AFTER THE CLEANING AND RINSING STEP FOR CORROSION, DAMAGED SURFACES, AND IMPURITIES. DO NOT FURTHER USE DAMAGED INSTRUMENTS." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.