BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER H-U 21MM/S1 *NOT CE*

    MDR report key: 18877541 · Received March 11, 2024

    Report

    Report Number
    8031010-2024-00022
    Event Type
    Malfunction
    Date Received
    March 11, 2024
    Date of Event
    October 15, 2019
    Report Date
    March 19, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 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 #151480(0) - MANUFACTURED ON 2012). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PROTAPER H-U 21MM/S1 FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447645 PROTAPER H-U 21MM/S1 *NOT CE* FILE, PULP CANAL, ENDODONTIC EKS MAILLEFER INSTRUMENTS HOLDING SARL 1514800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown