GATES RA 28MM 2 *NOT CE*

Additional Manufacturer Narrative

THE INVESTIGATION RESULTS FOR THIS COMPLAINT ARE BASED ON THE SENT PICTURE, THE INVOLVED GATE GLIDDEN DRILL RA 28MM #2 HAS BROKEN AT THE BASE OF THE NECK PORTION. NO FURTHER ANALYSIS CAN BE MADE AS THE PRODUCT IS NOT PHYSICALLY AVAILABLE. BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. NO UNUSED DRILL IS AVAILABLE FOR EVALUATION. THE BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. ROOT CAUSES ARE NOT 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 BEHAVIOR 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. ADDITIONAL INFORMATION RECEIVED: THE PATIENT DID NOT SUFFER ANY INJURY. ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT'S MOUTH. NO FURTHER MEDICAL OR SURGICAL TREATMENT WAS REQUIRED AFTER THE INCIDENT. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE -4580. HEALTH EFFECT - IMPACT CODE - 4648. THE PHYSICAL INVESTIGATION OF THE RETURNED ITEMS REVEALED THAT NO FRACTURE HAD OCCURRED. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 4582. HEALTH EFFECT - IMPACT CODE - 2199. THIS IS A FOLLOW UP REPORT TO CORRECT THESE/THIS CODE(S).

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.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A GATES RA 28MM 2 DRILL BROKE DURING USE FOR THE FIRST TIME. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.