BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGSWELL B ELEVATOR

    MDR report key: 7280528 · Received February 19, 2018

    Report

    Report Number
    0001032347-2018-00092
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Report Date
    August 6, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    PN/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A VISUAL INSPECTION OF THE RETURNED 09-0264 COGSWELL B ELEVATOR LOT# 120312K12 SHOWS SCRATCHES ALONG THE HANDLE, AND THE TIP IS FRACTURED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. MANUFACTURING HISTORY WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ELEVATOR FRACTURED DURING A PROCEDURE. THERE WAS NO DELAY OF SURGERY OR INJURY TO PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122960 COGSWELL B ELEVATOR ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 120312K12

    Patients

    Seq Age Sex Outcome Treatment
    1