MINI FIVE GRACEY CURETTE
Received Mar 14, 2019 · Event occurred Jan 29, 2019
Report 1416605-2019-00005 · MDR key 8423390
Device
Generic name
Curette, Periodontic
Manufacturer
Hu-friedy Mfg. Co. LlcModel number
SAS1/271Catalog number
SAS1/271
Lot number
T3
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
52 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PATIENT WEIGHT, ETHNICITY AND RACE UNKNOWN. THERE IS NO RELEVANT HISTORY. BASED ON THE LOT NUMBER OF THE DEVICE, THIS DEVICE WAS PRODUCED PRIOR TO THE UDI DEADLINE FOR CLASS I, THEREFORE UDI IS NOT PRESENT. THE DEVICE IS NOT IMPLANTED, THEREFORE IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. REPROCESSOR DOES NOT APPLY. NO KNOWN CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES. USER FACILITY/IMPORTER DOES NOT APPLY. IND IS NOT APPLICABLE. NOT APPLICABLE.
Description of Event or Problem
DURING A SURGICAL CLEANING ((B)(6) 2019) OF THE FURCATION AREA ON TOOTH 46, THE TIP FRACTURED OFF AND WAS LEFT IN SITU. PATIENT WAS ADVISED OF PROBLEM AND DENTIST WANTED TO SEE IF SHE HEALED AND TIP APPEARED. IT DID NOT, SO SHE RETURNED TO OFFICE AND IT WAS REMOVED SURGICALLY ON (B)(6) 2019.