BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5852776 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00068
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    July 24, 2014
    Report Date
    August 5, 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-1144 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. THIS CASE WAS SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION AND THE RETURN OF THE REPORTED DEVICE WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NOT ALL WERE PROVIDED, THEREFORE THERE WAS LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED, ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. THE DEVICE WAS NOT RETURNED TO CORIN UK FOR EXAMINATION, THEREFORE THE REPORTED FAILURE MODE COULD NOT BE VERIFIED. HOWEVER, AS A RESULT OF FEEDBACK FROM THE FIELD CORIN HAVE INITIATED A PROJECT TO REVIEW THE DESIGN OF THESE INSTRUMENTS. BASED ON THIS, CORIN NOW CONSIDERS 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.

    Description of Event or Problem · 1

    THE SCREW IN THE BLACK PLASTIC SECTION OF A TRINITY STD INTRODUCER / IMPACTOR HANDLE HAS BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507744 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL 921.129G 211811-03

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown