BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 6036251 · Received October 18, 2016

    Report

    Report Number
    9614209-2016-00153
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 15, 2016
    Report Date
    October 14, 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

    PER -3 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. THE REPORTED FAILURE MODE IN THIS CASE HAS BEEN REPORTED TO CORIN VIGILANCE PREVIOUSLY AND AS A RESULT OF FEEDBACK FROM THE FIELD, CORIN HAVE INITIED A PROJECT TO RESEARCH A NEW DESIGN FOR THIS INSTRUMENT, INCLUDING A NEW THREAD. BASED ON THIS, CORIN NOW CONSIDER 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

    IT WAS REPORTED THAT 2 TRINITY HANDLES HAD A BROKEN THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689978 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL 921.129G 206186-07

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown