BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO LINK ANCHOR 2.9MM

    MDR report key: 12689462 · Received October 25, 2021

    Report

    Report Number
    3006108336-2021-00050
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 28, 2021
    Report Date
    November 24, 2021
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    MBI
    UDI-DI
    00887868270161
    PMA / PMN Number
    K122314
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED, AS DEVICE REMAINS IMPLANTED AND INSERTER WAS DISCARDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). LINKED TO (B)(4). 0001825034-2021-02791. CONCOMITANT PRODUCTS: CM-0322 BRDBAND 2PK:BK/BL+BK LOT: 19110102. CM-9145 QUATTRO LINK ANCHOR 4.5MM LOT: 80138-2. CM-9129 QUATTRO LINK ANCHOR 2.9MM LOT: 74233-2. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LATERAL ANKLE STABILIZATION SURGERY, THE ANCHOR BROKE AND WAS UNABLE TO BE SUTURED AND WAS LEFT IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590554 QUATTRO LINK ANCHOR 2.9MM FASTENER, FIXATION MBI CAYENNE MEDICAL N/A 73193-2 00887868270161

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| O