HU-FRIENDLY SAS13/1498

Additional Manufacturer Narrative

THE PRACTICE RETURNED THE BROKEN DEVICE TO HU-FRIEDY ON (B)(4) 2013. THE RETURNED DEVICE WAS REVIEWED AND IT WAS DETERMINED ON (B)(4) 2013 THAT THIS WAS A NON-REPORTABLE INCIDENT. HOWEVER, ON (B)(4) 2013, HU-FRIEDY WAS NOTIFIED BY (B)(4)) THAT THE PRACTICE REPORTED THE BREAKAGE. THEREFORE, HU- FRIEDY IS SUBMITTING THIS REPORT ON (B)(4) 2013. RETURNED INSTRUMENT HAS BEEN OVER-SHARPENED BY THE END USER. THE ORIGINAL SHAPE OF THE WORKING END HAS BEEN ALTERED AND THE CUTTING EDGE IS EXCESSIVELY DULL. ADDITIONALLY, THIS TYPE OF INSTRUMENT (SCALERS) HAS A NORMAL LIFE EXPECTANCY OF 9-12 MONTHS. THE RETURNED INSTRUMENT WAS MANUFACTURED JUNE 2010. SECTION A- WEIGHT AND AGE OF PATIENT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE INFORMATION. SECTION D- HU-FRIEDY DOES NOT TRACK OUR DEVICES, WHICH ARE MOSTLY LOW RISK CLASS 1 DEVICES, BY SERIAL NUMBER, ONLY A LOT NUMBER 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. SECTION G- #5: ALL ARE NOT APPLICABLE. THIS IS A CLASS 1 EXEMPT DEVICE.

Description of Event or Problem

DURING A DENTAL PROCEDURE ON (B)(6) 2013, THE TIP OF THE DEVICE BROKE IN THE PATIENT'S MOUTH. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED. THE TIP WAS RETRIEVED AND THE PATIENT IS FINE.