BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO LINK ANCHOR 4.5MM

    MDR report key: 16775701 · Received April 20, 2023

    Report

    Report Number
    3006108336-2023-00013
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 24, 2023
    Report Date
    August 2, 2023
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    MBI
    UDI-DI
    00887868270192
    PMA / PMN Number
    K122314
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 : PART # CM-9011, QUATTRO SUTURE PASSER NEEDLE, LOT # 65623781; PART # 110025590, HYDDM RGD CANN 7X75MM, SINGLE, LOT # 190070; PART # CM-9145, QUATTRO LINK ANCHOR 4.5MM, LOT # 78350-2; PART # CM-9145SP, QUATTRO LINK ANCHOR 4.5MM, SP LOT # 65691578. CUSTOMER HAS NOT INDICATED IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE REPORTED EVENT IS NOT CONFIRMED. 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 THAT DURING SURGERY, THE ANCHOR CHIPPED. ALL FRAGMENTS WERE ABLE TO BE REMOVED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    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
    1558829 QUATTRO LINK ANCHOR 4.5MM FASTENER, FIXATION MBI CAYENNE MEDICAL N/A 65693357 00887868270192

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown