BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 9737913 · Received February 21, 2020

    Report

    Report Number
    9614209-2020-00019
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Report Date
    June 28, 2021
    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 · 0

    (B)(4) - FINAL REPORT THE SHELL WAS NOT RETURNED FOR EXAMINATION, THEREFORE THE INVESTIGATION WAS LIMITED. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORD HAS BEEN IDENTIFIED AND REVIEWED. ALL FINISHED PARTS ASSOCIATED WITH THIS RECORD CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE TRINITY STD INTRODUCER HANDLE WAS RETURNED AND THE FUNCTIONAL PARTS OF THE DEVICE ARE INTACT WITH NO DAMAGE. ASSESSMENT OF THE RETURNED INSTRUMENT FOUND THE DEVICE TO BE FUNCTIONALLY ACCEPTABLE. THEREFORE, CORIN NOW CONSIDERS 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 OCCURED OUTSIDE OF THE USA. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    DURING SURGERY THE DEFINITIVE IMPLANT COULD NOT BE UNSCREWED FROM THE HANDLE AND THUS HAD TO BE REMOVED. A SECOND TRINITY CUP AND TRINITY HANDLE WERE USED.

    Additional Manufacturer Narrative · 1

    PER (B)(4) INITIAL REPORT. THE DEVICE DETAILS FOR THE ASSOCIATED TRINITY CUP HAVE BEEN REQUESTED, ALONG WITH RETURN OF BOTH DEVICES, AND IF RECEIVED, THEY WILL BE REVIEWED AT CORIN. DETAILS OF THIS REVIEW SHALL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. UPON RECEIPT OF THE DEVICE DETAILS THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. 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

    DURING SURGERY THE DEFINITIVE IMPLANT COULD NOT BE UNSCREWED FROM THE HANDLE AND THUS HAD TO BE REMOVED. A SECOND TRINITY CUP AND TRINITY HANDLE WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205715 TRINITY STD INTRODUCER / IMPACTOR HANDLE, LWJ CORIN MEDICAL 921.129G 218810-02

    Patients

    Seq Age Sex Outcome Treatment
    1 TRINITY CUP - DEVICE DETAILS UNKNOWN| TRINITY CUP - DEVICE DETAILS UNKNOWN