BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 5881744 · Received August 17, 2016

    Report

    Report Number
    9614209-2016-00141
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    January 12, 2016
    Report Date
    August 17, 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. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. THIS CASE WAS SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW. NO ADVERSE EVENT REPORTED. UPON RECEIPT OF THE DEVICE AT CORIN (B)(4) THE REPORTED FAILURE MODE WAS VERIFIED, 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 DESIGN. 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 THREAD ON A TRINITY STD INTRODUCER/IMPACTOR HANDLE IS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536808 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL 921.129G NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown