BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENZTEC CLASSIC OCI - CORIN TRINKET

    MDR report key: 17037625 · Received June 1, 2023

    Report

    Report Number
    3004641308-2023-00001
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 1, 2023
    Manufacturer
    ENZTEC LIMITED
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING CUP IMPACTION OF A THR SURGERY IN AUSTRALIA, THE OFFSET CUP IMPACTOR TRINKET THREAD BECAME STUCK IN THE DEFINITIVE CUP IMPLANT. SURGEON ATTEMPTED TO UNSCREW THE IMPACTOR USING THE SCREWDRIVER ATTACHMENT AND THE CUP DISLODGED. SURGEON REAMED UP A SIZE AND IMPACTED CUP IMPLANT USING AN ALTERNATE BACKUP INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830492 ENZTEC CLASSIC OCI - CORIN TRINKET OCI TRINKET HWA ENZTEC LIMITED 3991055001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention ENZTEC CLASSIC OCI - CORIN