BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-REAMER M-ACCESS 25MM 015

    MDR report key: 19116798 · Received April 16, 2024

    Report

    Report Number
    8031010-2024-00041
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 23, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKP
    UDI-DI
    J003A11MA025015121
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 #1729207). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A K-REAMER M-ACCESS 25MM FILE BROKE DURING USE. THE BROKEN PARTS COULD NOT BE RETRIEVED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262636 K-REAMER M-ACCESS 25MM 015 REAMER, PULP CANAL, ENDODONTIC EKP MAILLEFER INSTRUMENTS HOLDING SARL 1729207 J003A11MA025015121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male