BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5849641 · Received August 5, 2016

    Report

    Report Number
    9614209-2015-00074
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    September 29, 2015
    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

    (B)(4) - INITIAL REPORT. DEVICE DETAILS AND PATIENT OUTCOME ALONG WITH THE RETURN OF THE REPORTED INSTRUMENT HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE MANUFACTURING RECORDS WILL BE REVIEWED ONCE THE RELEVANT DEVICE DETAILS HAVE BEEN RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS, A DETAILED PATIENT OUTCOME AND THE RETURN OF THE REPORTED DEVICE WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION. THE INITIAL REPORTER TO CORIN UK CONFIRMED THAT THE PATIENT WAS NOT AFFECTED BY THIS EVENT. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED, IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THESE RECORDS CONFOMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. UPON RECEIPT OF THE INSTRUMENT AT CORIN UK THE REPORTED FAILURE MODE WAS VERIFIED. THESE INSTRUMENTS ARE MANUFACTURED ON BEHALF OF CORIN BY A THIRD PARTY, THEREFORE THIS DEVICE HAS BEEN RETURNED TO THEM FOR THEIR OWN INVESTIGATION. 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 INNER SHAFT OF A TRINITY MIS REAMER HANDLE IS BROKEN.

    Description of Event or Problem · 1

    THE INNER SHAFT OF A TRINITY MIS REAMER HANDLE IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501425 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL A399.110 059229-025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other