BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCAVATOR DOUBLE ENDED USA 17

    MDR report key: 23862605 · Received December 22, 2025

    Report

    Report Number
    8031010-2025-00237
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Report Date
    January 28, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKC
    UDI-DI
    J003B095SA00175001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION RESULTS FOR THIS COMPLAINT ARE: INVOLVED EXCAVATOR DOUBLE ENDED USA 17 THAT BROKE DURING USE WAS NOT RETURNED. PROVIDED PICTURE IS NOT ENOUGH FOR ANALYSIS (ANALYSIS MUST MADE UNDER HIGH MAGNIFICATION AND REQUIRES THAT THE INVOLVED IS PHYSICALLY AVAILABLE). NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1781798). 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, 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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A EXCAVATOR DOUBLE ENDED BROKE DURING USE. THE BROKEN PART WAS REMOVED AND THERE WAS NO NEED FOR ANY ADDITIONAL TREATMENT. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688932 EXCAVATOR DOUBLE ENDED USA 17 EXCAVATOR, DENTAL, OPERATIVE EKC MAILLEFER INSTRUMENTS HOLDING SARL UNKNOWN J003B095SA00175001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown