BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 6019932 · Received October 12, 2016

    Report

    Report Number
    9614209-2016-00076
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    July 29, 2015
    Report Date
    March 11, 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

    C-1527 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. ADDITIONAL INFORMATION INCLUDING DEVICE DETAILS AND THE RETURN OF THE DEVICE WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER NOT ALL WERE PROVIDED, THEREFORE, THERE WAS LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THIS INSTRUMENT IS MANUFACTURED FOR CORIN BY GREATBATCH, THEREFORE, A COMPLAINT HAS BEEN RAISED WITH THE SUPPLIER AND THE DEVICE SENT TO THEM FOR REVIEW. CORIN HAVE PROVIDED THE CUSTOMER WITH A REPLACEMENT INSTRUMENT. 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 JOINT ON A TRINITY MIS INTRODUCER HANDLE HAS BROKEN. DURING THE OPERATION METAL CUTTINGS FELL OFF AND INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676299 TRINITY ACETABULAR HIP SYSTEM LWJ CORIN MEDICAL A399.110 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown