BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5972956 · Received September 23, 2016

    Report

    Report Number
    9614209-2016-00152
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    July 25, 2016
    Report Date
    October 21, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LWJ
    PMA / PMN Number
    K110087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO AE REPORTED. ADDITIONAL INFORMATION INCLUDING DEVICE DETAILS AND FURTHER EVENT DETAILS HAVE BEEN REQUESTED FOR THE INVESTIGATION. PLEASE NOTE: THIS EVENT DID NOT OCCUR IN THE USA. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. NO AE REPORTED. ADDITIONAL INFORMATION, INCLUDING A SPECIFIC FAILURE MODE, DEVICE LOT CODE AND THE RETURN OF THE DEVICE WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NONE WERE PROVIDED AND THEREFORE THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE DEVICE LOT CODE WAS UNAVAILABLE AND THUS THE DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. THE DEVICE ITSELF WAS DISCARDED BY THE HOSPITAL AND THEREFORE COULD NOT BE EXAMINED. BASED ON THIS, A ROOT CAUSE COULD NOT BE IDENTIFIED AND CORIN NOW CONSIDER THIS CASE CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    TRINITY REAMER HANDLE BROKE DURING SURGERY.

    Description of Event or Problem · 1

    TRINITY REAMER HANDLE BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626867 TRINITY ACETABULAR REAMER INSTRUMENT LWJ CORIN MEDICAL Z399.110 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1