BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5852909 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00058
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Report Date
    August 8, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-1428 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS, A PATIENT OUTCOME AND THE INSTRUMENT WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NONE WERE PROVIDED TO CORIN UK. THEREFORE, THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE NOT PROVIDED, THUS, THE RELEVANT DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. THE INSTRUMENT WAS NOT RETURNED TO CORIN FOR EXAMINATION SO A FAILURE MODE AND ROOT CAUSE COULD NOT BE VERIFIED. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. 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

    IT WAS REPORTED THAT A TRINITY MODULAR DRIVE SHAFT INSTRUMENT IS BROKEN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507714 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL 921.103 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown