BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO LINK SP KNOTLESS ANCHOR

    MDR report key: 19428768 · Received May 29, 2024

    Report

    Report Number
    MW5155580
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 23, 2024
    Report Date
    May 24, 2024
    Manufacturer
    CAYENNE MEDICAL, INC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS UNDERGOING RIGHT SHOULDER SURGERY. SURGEON WAS USING A QUATTRO LINK SP KNOTLESS ANCHOR AND THE TIP OF THE DEVICE BROKE OFF IN PATIENT. SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECES OF THE DEVICE AND THE SURGERY WAS COMPLETED. NO HARM TO PATIENT WAS NOTED. CAYENNE MEDICAL A ZIMMER BIOMET COMPANY. UNIQUE DEVICE IDENTIFIER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329800 QUATTRO LINK SP KNOTLESS ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CAYENNE MEDICAL, INC CM-9145SP 66267346

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention