BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO X

    MDR report key: 6669083 · Received June 27, 2017

    Report

    Report Number
    3006108336-2017-00003
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    CAYENNE MEDICAL, INC
    Product Code
    MBI
    PMA / PMN Number
    K112814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A ROTATOR CUFF RECONSTRUCTION PROCEDURE WAS PERFORMED USING QUATTRO X SUTURE ANCHOR PRODUCT AND IT WAS REPORTED THAT THE DRIVER HANDLE BROKE WHEN DEPLOYING THE FIRST SUTURE ANCHOR. IT WAS ALSO REPORTED THAT THE FIRST SUTURE ANCHOR PIECES WERE LEFT IN THE PATIENT AND A NEW SUTURE ANCHOR WAS DEPLOYED IN A NEW DRILLED HOLE WHICH CAUSED A 30 MINUTES DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449850 QUATTRO X SUTURE ANCHOR MBI CAYENNE MEDICAL, INC CM-9255 60533-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other