BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCAVATOR DOUBLE ENDED USA 5

    MDR report key: 15924026 · Received December 6, 2022

    Report

    Report Number
    8031010-2022-00703
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Report Date
    February 21, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    EKC
    PMA / PMN Number
    EXEMPT
    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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION UPDATE: DEVICES HAVE BEEN RETURNED. THE TWO RETURNED EXCAVATORS DOUBLE ENDED USA 5 HAVE EACH ONE BROKEN ACTIVE PART. BREAKAGES OCCURRED AT THE BASE OF THE PALLETS. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERNS. SECOND ACTIVE PARTS ARE NOT DAMAGED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1749719). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. ADDITIONAL FDA CODING BEING ADDED AFTER INVESTIGATION OF DEVICE. ADDING ADDITIONAL TYPE OF INVESTIGATION CODE 10. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: TYPE OF INVESTIGATION CODE - 4114. REMOVING CODE DUE TO DEVICE BEING RETURNED AND INSPECTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1749719). 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 EXCAVATOR DOUBLE ENDED USA 5 EXCAVATOR TIP 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
    1852516 EXCAVATOR DOUBLE ENDED USA 5 EXCAVATOR, DENTAL, OPERATIVE EKC MAILLEFER INSTRUMENTS HOLDING SARL 1749719

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown