BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 8681900 · Received June 10, 2019

    Report

    Report Number
    9614209-2019-00041
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 8, 2019
    Report Date
    June 25, 2020
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K093472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER -2123 FINAL REPORT. IT WAS REPORTED THAT THE DEVICES BROKE NEAR THE END DURING INSERTION DUE TO DENSE BONE AND OVER-TORQUEING. IT WAS CONFIRMED THAT THE DEVICES WERE DISCARDED FOLLOWING SURGERY AND THUS COULD NOT BE RETURNED FOR EXAMINATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEIWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. BASED ON THE AVAILABLE INFORMATION IS HAS BEEN CONCLUDED THAT THIS EVENT WAS THE RESULT OF THE DENSITY OF THE PATIENTS BONE AND POTENTIAL OVER-TORQUEING DURING THE INSERTION. THEREFORE, CORIN NOW CONSIDERS THIS CASE CLOSED. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    TRINITY SCREW BROKE DURING MANUAL INSERTION. ALL BROKEN PARTS WERE RETRIEVED AND NONE WERE LEFT IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION INCLUDING POST-OPERATIVE X-RAYS AND A DETAILED PATIENT OUTCOME HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. IT HAS BEEN CONFIRMED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO RETURN FOR EXAMINATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN 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.

    Description of Event or Problem · 1

    TRINITY SCREW BROKE DURING MANUAL INSERTION. ALL BROKEN PARTS WERE RETRIEVED AND NONE WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478846 TRINITY CANCELLOUS BONE SCREW LZO CORIN MEDICAL 321.050 414298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention