BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO LINK KNOTLESS ANCHOR

    MDR report key: 20746060 · Received November 21, 2024

    Report

    Report Number
    3006108336-2024-00042
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    April 8, 2024
    Report Date
    December 11, 2024
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    MBI
    PMA / PMN Number
    K122314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: AUSTRALIA. THE REPORTED EVENT WAS IDENTIFIED DURING REVIEW OF A JOURNAL ARTICLE GUPTA, ASHISH ET AL. ALL-ARTHROSCOPIC SUPRASPINATUS AND INFRASPINATUS MUSCLE ADVANCEMENT LEADS TO HIGH HEALING RATE AND EXCELLENT OUTCOMES IN PATIENTS WITH MASSIVE, RETRACTED ROTATOR CUFF TEARS, EVEN IN PATIENTS WITH PSEUDOPARALYSIS (2024). ARTHROSCOPY, VOLUME 40, ISSUE 12, 2801 - 2811. HTTPS://DOI.ORG/10.1016/J.ARTHRO.2024.03.041.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. IT IS UNKNOWN WHAT PATIENT THE PICTURES IN THE JA CORRELATE TO. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT ONE PATIENT DEVELOPED A PROPIONIBACTERIUM ACNES INFECTION 6 WEEKS POST-OPERATIVE. A WASHOUT WAS PERFORMED AND THE POSTERIOR PART OF THE SUPRASPINATUS WAS NOTED TO HAVE FAILED AND WAS TREATED CONSERVATIVELY. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908275 QUATTRO LINK KNOTLESS ANCHOR FASTENER, FIXATION MBI CAYENNE MEDICAL N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R