BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-FILE M-ACCESS 25MM 030

    MDR report key: 23745026 · Received December 8, 2025

    Report

    Report Number
    8031010-2025-00223
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    J003A12MA025030121
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED; WE RECEIVED THE FOLLOWING INFORMATION REGARDING THIS COMPLAINT THE SALES CONTACTED THE CLINIC CONTACT AND GOT THAT THE CASE DID NOT ACTUALLY OCCURRED. PLEASE VOID IT. WE WILL AT LEAST REVIEW THE DHR. 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 #1771406). 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. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. CORRECTING THIS EVENT FROM REPORTABLE TO NON REPORTABLE. INFORMATION WAS RECEIVED THAT THIS EVENT DID NOT ACTUALLY HAPPEN, PLEASE DISREGARD THE INITIAL REPORT. AS A COURTESY WE HAVE INCLUDED THE INVESTIGATION RESULTS EVEN THOUGH THIS IS NOT A REPORTABLE EVENT. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR 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 · 0

    IN THIS EVENT IT IS REPORTED THAT A K-FILE M-ACCESS 25MM 030 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE SUCCESSFULLY REMOVED. TO RELIEVE THE PAIN THE PATIENT WAS IN THE TOOTH WAS EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15269 K-FILE M-ACCESS 25MM 030 FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1771406 J003A12MA025030121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown