BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 6193007 · Received December 21, 2016

    Report

    Report Number
    9614209-2016-00162
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    October 12, 2016
    Report Date
    February 8, 2017
    Manufacturer
    CORIN MEDICAL
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER -145 FINAL REPORT. NO ADVERSE EVENT REPORTED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED, IT WAS FOUND THAT THIS DEVICE CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. THE REPORTED FAILURE MODE IN THIS CASE HAS BEEN REPORTED TO CORIN PREVIOUSLY AND AS A RESULT OF FEEDBACK FROM THE FIELD, CORIN HAVE INITIATED A PROJECT TO RESEARCH A NEW DESIGN FOR THIS INSTRUMENT, INCLUDING A NEW THREAD. BASED ON THIS, CORIN NOW CONSIDER THIS CASE CLOSED.

    Additional Manufacturer Narrative · 1

    PER -145 INITIAL REPORT NO ADVERSE EVENT REPORTED. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORD WILL BE RETRIEVED AND REVIEWED AND DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THIS INVESTIGATION. THE REPORTED FAILURE MODE IN THIS CASE HAS BEEN REPORTED TO CORIN PREVIOUSLY AND AS A RESULT OF FEEDBACK FROM THE FIELD, CORIN HAVE INITIATED A PROJECT TO RESEARCH A NEW DESIGN FOR THIS INSTRUMENT, INCLUDING A NEW THREAD. BASED ON THIS, CORIN NOW CONSIDER THIS CASE CLOSED.

    Description of Event or Problem · 1

    THE THREAD OF A TRINITY STD INTRODUCER / IMPACTOR HANDLE IS DAMAGED.

    Description of Event or Problem · 1

    THE THREAD OF A TRINITY STD INTRODUCER / IMPACTOR HANDLE IS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846709 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL 921.129 286693-10

    Patients

    Seq Age Sex Outcome Treatment
    1