BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP EMS INSERT 2

    MDR report key: 17032363 · Received May 31, 2023

    Report

    Report Number
    8031010-2023-00795
    Event Type
    Malfunction
    Date Received
    May 31, 2023
    Date of Event
    May 17, 2023
    Report Date
    July 24, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY: RETURNED START-X TIP EMS INSERT 2 IS ACTUALLY BROKEN IN THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED DEVICE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1772251). NO INFORMATION WAS GIVEN REGARDING TECHNIQUE, WE CANNOT RULE ON ITS COMPLIANCE WITH MAILLEFER'S RECOMMENDATIONS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT START-X TIP EMS INSERT 2 BROKE DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836877 START-X TIP EMS INSERT 2 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1772251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown