K-REAMER M-ACCESS 21MM 020

Additional Manufacturer Narrative

AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, 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.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A K-REAMER M-ACCESS 21MM 020 BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED, LEFT IN THE CANAL. PATIENT HAS NO ADVERSE REACTIONS. NO INJURY.

Additional Manufacturer Narrative

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 #1745615). 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 (NUMBER OF USES NOT COMMUNICATED), 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.