BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C+FILE READYSTEEL 25MM 008

    MDR report key: 24496876 · Received March 3, 2026

    Report

    Report Number
    8031010-2026-00023
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Report Date
    March 25, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    UDI-DI
    D71667008251
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    SUMMARY: INVOLVED C+FILES READYSTEEL 25MM 008 THAT BROKE OR THAT BENT DURING USE WERE NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1932732). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, 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. WE RECEIVED THE FOLLOWING INFORMATION REGARDING THIS COMPLAINT: HAS ANY PATIENT BEEN INJURED? [NO]. HAVE ALL THE BROKEN PARTS BEEN RETRIEVED FROM PATIENT¿S MOUTH? [YES]. HAS ANY FURTHER MEDICAL OR SURGICAL TREATMENT BEEN NECESSARY AFTER THE EVENT? [NO]. HOW MANY TIMES HAS THE INSTRUMENT BEEN USED BEFORE THE EVENT HAPPENED? [AFTER USING SEVERAL FILES FROM THE PACKAGE, THE DOCTOR DECIDED THEY NO LONGER HAVE STRENGTHS, AND THEY TO BREAK MORE QUICKLY COMPARED TO PREVIOUSLY PURCHASED TOOLS OF THE SAME TYPE]. 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 CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 4582. HEALTH EFFECT - IMPACT CODE - 4648. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A C+FILE READYSTEEL 25MM 008 FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556000 C+FILE READYSTEEL 25MM 008 FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1932732 D71667008251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown