BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRUMME RONGEUR

    MDR report key: 6339949 · Received February 17, 2017

    Report

    Report Number
    9615005-2017-80003
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 20, 2017
    Report Date
    May 5, 2017
    Manufacturer
    FEHLING INSTRUMENTS GMBH & CO. KG
    Product Code
    HTX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO THE REASON THAT DEVICE WAS NOT RETURNED FOR INVESTIGATION WE CANNOT PERFORM A PROPER ROUTE CAUSE ANALYSIS. ALL FROM OUR SIDE POSSIBLE INVESTIGATIONS WERE MADE. IN CASE WE RECEIVE THE DAMAGED DEVICE WE WILL OPEN THE CASE AGAIN.

    Description of Event or Problem · 0

    THIS MDR IS RELATED TO MDR 9615005-2017-80003. IT'S THE FOLLOW-UP WITH THE FINAL RESULTS OF THE INVESTIGATION. ACCORDING TO REPORT FROM HOSPITAL (EVENT NO. (B)(4), REPORTED 01/22/2017) RONGEUR (ARTICLE NUMBER NLU-2, LOT 12K356J, MANUFACTURING YEAR 2013) BROKE DURING SURGERY WHICH WAS NOTICED IN CSS. SMALL METAL PEACE WAS SEEN ON X-RAY. CT SCAN CONFIRMED METAL RETAINED. INCISION WAS REOPENED AT BEDSIDE. FRAGMENT WAS RETRIEVED . RETRIEVED FRAGMENT WAS SMALLER THAN THE MISSING PART FROM RONGEUR. ADDITIONAL X-RAY TAKEN. NO OTHER METAL WAS SEEN.

    Additional Manufacturer Narrative · 1

    DEVICE STILL IN HOSPITAL.

    Description of Event or Problem · 1

    DURING SURGERY THE JAW OF THE RONGUER (ARTICLE NUMBER NLU-2, LOT 12K356J, MANUFACTURING YEAR 2013) BROKE APART. AS OF OUR KNOWLEDGE OF TODAY THE FRAGMENT WAS REMOVED COMPLETELY. NO PART WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124209 GRUMME RONGEUR RONGEUR, PRODUCT CODE: HTX HTX FEHLING INSTRUMENTS GMBH & CO. KG 12K356J

    Patients

    Seq Age Sex Outcome Treatment
    1