K-REAMER M-ACCESS 25MM 010

Additional Manufacturer Narrative

ADDITIONAL INFORMATION RECEIVED: THE BROKEN FILE IN THE PATIENT'S MOUTH HAS ALSO BEEN WASHED OUT, AND THERE IS NO BROKEN PART IN THE ROOT CANAL AFTERWARDS. DUE TO THE FACT THAT THE PATIENT IS AN ELDERLY PERSON, THE CONDITION OF THE CANAL IS RELATIVELY COMPLEX, WITH SEVERE CALCIFICATION AND CURVATURE, WHICH ARE ALSO PART OF THE REASONS FOR THIS CASE. THE FILE UNDERWENT THREE TIMES OF HIGH TEMPERATURE AND HIGH PRESSURE DISINFECTION BEFORE BREAKING (USUALLY DISINFECTED 5-7 TIMES BEFORE BEING CLINICALLY SCRAPPED), AND THE PRODUCT WAS NOT RETAINED. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. INVESTIGATION RESULTS: SUMMARY: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1881490). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE (HAND USED FILE - TECHNIQUE NO MORE VERIFIABLE TO DATE), OVERUSE (FILE USED SEVERAL TIMES - MULTIPLE USES MAY INCREASE RISKS OF BREAKAGES), 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. 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 CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 4582. HEALTH EFFECT - IMPACT CODE - 4624. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

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. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED AND WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A K-REAMER M-ACCESS 25MM 010 BROKE DURING USE. THE BROKEN PART WAS RETRIEVED BY ULTRASONIC WASHING. REPORTEDLY, THIS PROCESS CAUSED SOME HARM TO THE PATIENT, DOCTOR DID NOT MENTION ANY SPECIFIC INJURY. FURTHER INFORMATION REQUESTED.