UNIMETRIC TITANIUM SET 0.8

Additional Manufacturer Narrative

SUMMARY: NO PRODUCT WAS RETURNED. BASED ON THE PICTURES PROVIDED BY THE CUSTOMER, THE INSTRUMENT WHICH HAS BROKEN DURING USE WAS IDENTIFIED AS A PENETRATION DRILL C0212200308, PART OF AN UNIMETRIC TITANIUM SET 0.8. BREAKAGE OCCURRED AT THE BASE OF THE OPERATING PART WHERE THE SHANK IS THE THINNEST (EXPECTED LOCATION). PICTURE RESOLUTION DOES NOT ALLOW FURTHER ANALYSIS (PRESENCE OF MATERIAL DEFECT, RUPTURE PATTERN, CUTTING EDGES USURY, MEASUREMENTS). NO UNUSED PENETRATION DRILL IS AVAILABLE FOR EVENTUAL EVALUATION. ON THE OTHER HAND, THE BATCH NUMBER WAS NOT PROVIDED, DHR CANNOT BE REVIEWED. ROOT CAUSES OF THE BREAKAGE CANNOT BE IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, OVERUSE, EXCESSIVE WEAR, PATIENT CONDITION AND BEHAVIOUR DURING TREATMENT OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). IN ADDITION, THERE ARE FURTHER CIRCUMSTANCES ON THE CONDITIONS IN DENTISTRY (USED DISINFECTANTS, TRAINING/KNOWLEDGE STATUS), OR ANY OTHER ENVIRONMENTAL CONDITIONS, WHICH ARE UNKNOWN TO US AND MAY ALSO HAVE AN IMPACT ON THE REPORTED FAILURE MODE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A UNIMETRIC TITANIUM SET 0.8 BROKE DURING USE. REPORTEDLY, NO INJURY. FURTHER INFORMATION REQUESTED.

Additional Manufacturer Narrative

THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.