HU-FRIEDY #23/UNC 15 EXPRO, #7 HANDLE

Description of Event or Problem

DURING A DENTAL EXAMINATION TO MEASURE POCKET DEPTHS ON (B)(6) 2013, THE TIP OF THE DEVICE BROKE IN THE PATIENT'S MOUTH. MEASUREMENT WAS TAKEN ON THE UPPER LEFT JAW IN REGION 27. THE TIP WAS REMOVED AND PATIENT IS FINE. THE PRACTICE RETURNED THE BROKEN DEVICE TO OUR HU-FRIEDY ON (B)(4) 2013.

Additional Manufacturer Narrative

RETURNED INSTRUMENT APPEARS TO HAVE BROKEN BY APPLYING REPETITIVE FORCE (BACK AND FORTH) HIGHER THAN MATERIAL CAPABILITY, CAUSING TIP TO BEND AND EVENTUALLY RESULTING IN BREAKAGE. WE CURRENTLY HAVE A VERY LOW LEVEL OF RETURNS FOR THIS PRODUCT OVER THE LAST 12 MONTHS. THEREFORE, NO FURTHER ACTION WILL TAKE PLACE AT THIS TIME BUT WE WILL CONTINUE TO MONITOR. WEIGHT AND AGE OF PATIENT IS NOT KNOWN, OFFICE WAS NOT ABLE TO PROVIDE INFORMATION. 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 AN EXPIRATION DATE. THE DEVICE IS NOT IMPLANTED, THEREFORE, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. PMA/510(K): ALL ARE NOT APPLICABLE. THIS IS A CLASS 1 EXEMPT DEVICE.