BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5881727 · Received August 17, 2016

    Report

    Report Number
    9614209-2016-00134
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    July 15, 2016
    Report Date
    August 17, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-2035 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. NO ADVERSE EVENT REPORTED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. THE FAILURE MODE HAS BEEN REPORTED TO CORIN VIGILANCE PREVIOUSLY AND AS A RESULT OF THIS FEEDBACK, CORIN HAVE INITIATED A PROJECT TO RESEARCH IMPLEMENTING A NEW THREAD DESIGN FOR THIS INSTRUMENT. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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.

    Description of Event or Problem · 1

    THE THREAD ON A TRINITY STD INTRODUCER/IMPACTOR HANDLE HAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536744 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL 921.129G 318620-05

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown