BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY

    MDR report key: 5849645 · Received August 5, 2016

    Report

    Report Number
    9614209-2015-00075
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    November 4, 2015
    Report Date
    August 5, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    JWH
    PMA / PMN Number
    K113060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INITIAL REPORT. THE REPORTED INSTRUMENT HAS BEEN REQUESTED FOR EXAMINATION, AND IF RECEIVED THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE INITIAL REPORTER TO CORIN CONFIRMED THAT THIS EVENT OCCURRED IN THE HEALTHCARE FACILITY STERILE SERVICES DEPARTMENT AND THUS THERE WAS NO PATIENT INVOLVED. DEVICE MANUFACTURING RECORDS WILL BE REVIEWED IF THE RELEVANT DEVICE DETAILS ARE PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS AND THE RETURN OF THE INSTRUMENT WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE RETRIEVED AND REVIEWED, IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED IN 2013. WHEN REVIEWING THE RETURNED INSTRUMENT AT CORIN UK, THE REPORTED FAILURE MODE WAS VERIFIED. THE PIN HAD BROKEN AWAY FROM THE DEVICE DUE TO FAILURE OF THE WELD DESIGNED TO HOLD THE PIN IN PLACE. THIS INSTRUMENT IS MANUFACTURED BY A SUB-CONTRACTOR SO CORIN HAVE RETURNED THIS DEVICE TO THEM FOR REWORK. CORIN WILL CONTINUE TO MONITOR TRENDS RELATING TO THIS OR SIMILAR FAILURE MODES. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED. SHOULD ANY NEW INFORMATION COME TO LIGHT THIS CASE WILL BE RE-OPENED FOR FURTHER INVESTIGATION. 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 PIN HAS BROKEN OFF FROM A UNITY GUIDANCE DISTAL CUTTING BLOCK INSTRUMENT.

    Description of Event or Problem · 1

    THE PIN HAS BROKEN OFF OF A UNITY GUIDANCE DISTAL CUTTING BLOCK INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501426 UNITY TOTAL KNEE SYSTEM JWH CORIN MEDICAL 123.306.00 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other