BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 6697458 · Received July 10, 2017

    Report

    Report Number
    9614209-2017-00048
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 7, 2017
    Report Date
    September 17, 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 · 1

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING THE RETURN OF THE PART OF THE DEVICE WHICH HAD NOT BEEN LEFT IN THE PATIENT AND DETAILS OF THE IMPLICATIONS THIS EVENT HAD ON THE SURGERY AND THE PATIENT, WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NOT ALL WAS AVAILABLE AND THUS THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. CORIN HAVE REVIEWED THE COMPLAINTS DATA FOR THE PART NO. 321.030 AND HAS IDENTIFIED THAT THIS IS THE ONLY REPORT RECEIVED REGARDING THIS TRINITY SCREW BREAKING AND THUS IS AN ISOLATED EVENT. BASED ON THIS, CORIN NOW CONSIDER 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 OCCURRED OUTSIDE OF THE USA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING RETURN OF THE PART OF THE BROKEN DEVICE WHICH WAS NOT LEFT IN THE PATIENT AND DETAILS ON THE IMPLICATIONS THIS EVENT HAD ON THE SURGERY AND THE PATIENT HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. 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

    TRINITY CANCELLOUS SCREW BROKE DURING SURGERY. PART OF THE SCREW WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    TRINITY CANCELLOUS SCREW BROKE DURING SURGERY. PART OF THE SCREW WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478650 TRINITY CANCELLOUS SCREW LWJ CORIN MEDICAL 321.030 358257

    Patients

    Seq Age Sex Outcome Treatment
    1