BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5853709 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00105
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 22, 2018
    Manufacturer
    CORIN MEDICAL
    Product Code
    LWJ
    PMA / PMN Number
    K093472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT. THIS EVENT REPORT WAS INITIALLY SUBMITTED AS IT WAS THOUGHT TO CONCERN A CORIN INSTRUMENT. HOWEVER, AS A RESULT OF INVESTIGATIONS IT WAS IDENTIFIED THAT THIS INSTRUMENT WAS NOT MANUFACTURED BY CORIN AND THUS CORIN CONSIDERS THIS FILE 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 OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CORIN REAMER HANDLE HAD BROKEN AND DAMAGE WAS OBSERVED TO THE INTERNAL MECHANISM, HOWEVER, IT HAS BEEN IDENTIFIED IN THE INVESTIGATION OF THIS EVENT THAT THIS WAS NOT A CORIN DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT (B)(4). NO AE REPORTED. ADDITIONAL INFORMATION INCLUDING DEVICE DETAILS AND THE RETURN OF THE 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. THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE RETRIEVED AND REVIEWED UPON RECEIPT OF THE APPROPRIATE DEVICE DETAILS. 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

    THE PROXIMAL END OF A CHANA REAMER HANDLE HAS BROKEN AND DAMAGE WAS OBSERVED TO THE INTERNAL MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505791 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL Z399.110 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1