BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRINITY

    MDR report key: 9737908 · Received February 21, 2020

    Report

    Report Number
    9614209-2020-00018
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    January 30, 2020
    Report Date
    July 19, 2021
    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 · 0

    PER 2762 - FINAL REPORT. THE CUP AND THE HANDLE WERE NOT RETURNED FOR EXAMINATION, THEREFORE THE INVESTIGATION WAS LIMITED. THE APPROPRIATE DEVICE DETAILS (PART NUMBER AND LOT CODE) WERE NOT PROVIDED, AND CONSEQUENTLY THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE NOT BEEN IDENTIFIED AND REVIEWED. FURTHERMORE, THE REPORTED DEVICE WAS UNABLE TO BE RETURNED AND THE FAILURE MODE COULD NOT BE CONFIRMED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY CORIN. THEREFORE, 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 OCCURED OUTSIDE OF THE USA. 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 CUP BECAME STUCK ON THE TRINITY STD INTRODUCER / IMPACTOR HANDLE DURING SURGERY. THE CUP WAS REMOVED AND THE SURGEON THEN RE-REAMED AND IMPLANTED A LARGER SIZE CUP WITH A NEW HANDLE.

    Additional Manufacturer Narrative · 1

    PER (B)(4) INITIAL REPORT. DEVICE DETAILS AND RETURN OF THE REPORTED DEVICES HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT, AND IF RECEIVED, WILL BE REVIEWED AT CORIN. DETAILS OF THIS REVIEW WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. UPON RECEIPT OF THE APPROPRIATE DEVICE DETAILS, 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 CUP BECAME STUCK ON THE TRINITY STD INTRODUCER / IMPACTOR HANDLE DURING SURGERY. THE CUP WAS REMOVED AND THE SURGEON THEN RE-REAMED AND IMPLANTED A LARGER SIZE CUP WITH A NEW HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205700 TRINITY STD INTRODUCER / IMPACTOR HANDLE LWJ CORIN MEDICAL NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 TRINITY CUP - DEVICE DETAILS NOT PROVIDED| TRINITY CUP - DEVICE DETAILS NOT PROVIDED