BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    QUATTRO LINK KNOTLESS ANCHOR

    MDR report key: 20746020 · Received November 21, 2024

    Report

    Report Number
    3006108336-2024-00041
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    April 8, 2024
    Report Date
    March 25, 2026
    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. UPDATED. SUPERFICIAL INFECTIONS ARE CONSIDERED A PROCEDURE RELATED COMPLICATION AS NO DEVICE HAS BEEN REPORTED AS REVISED. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE NOT REVIEWED, AS NO PRODUCT PART/LOT INFORMATION WAS PROVIDED. ALL DEVICES MANUFACTURED FOLLOW ACCEPTABLE STERILIZATION PROCESSES ACCORDING TO PUBLISHED ISO/AAMI/ASTM & EU GUIDELINES. A SUPERFICIAL INFECTION WAS REPORTED AND NO PRODUCT INFORMATION WAS PROVIDED; THEREFORE, VALIDATION OF STERILE CERTIFICATIONS CANNOT BE PERFORMED. HOWEVER, THE REPORTED EVENT IS CONSIDERED PROCEDURE-RELATED RATHER THAN DEVICE RELATED AS THE DEEP JOINT WAS FOUND ABSENT OF INFECTION. 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 PRESENTED WITH A PORTAL INFECTION. EXCISION AND THOROUGH DEBRIDEMENT OF THE PORTAL WAS PERFORMED AND DIAGNOSTIC ARTHROSCOPY CONFIRMED THE ABSENCE OF A DEEP INFECTION. THE REPAIRED CUFF WAS NOTED TO BE HEALED AND A WASHOUT OF THE JOINT WAS PERFORMED. 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
    1970574 QUATTRO LINK KNOTLESS ANCHOR FASTENER, FIXATION MBI CAYENNE MEDICAL N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R