BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRO LINK ANCHOR 4.5MM SP

    MDR report key: 12376998 · Received August 27, 2021

    Report

    Report Number
    3006108336-2021-00035
    Event Type
    Injury
    Date Received
    August 27, 2021
    Date of Event
    August 3, 2021
    Report Date
    October 22, 2021
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    MBI
    UDI-DI
    00887868270208
    PMA / PMN Number
    K122314
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; 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). CONCOMITANT MEDICAL DEVICES: PN CM-9145SP QUATTRO LINK ANCHOR 4.5MM SP LN 78350-3; PN CM-9011 QUATTRO SUTURE PASSER NEEDLE LN 77980-1. FOREIGN : (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROTATOR CUFF ATTACHMENT, A QUATTRO LINK KNOTLESS ANCHOR BROKE INSIDE THE PATIENT. DURING SURGERY, WHEN IMPACTING THE CAYENNE KNOTLESS 4.5MM ANCHOR, UNTIL THE FIRST MARK, IT IS BROKEN, LEAVING ONLY THE TIP IN THE PATIENT'S BONE AND THE REST WITH THE HANDLE REMAINED IN THE DOCTOR'S HAND. THE STEPS TO PLACE ANCHOR WERE DONE ACCORDING TO THE TECHNIQUE. 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
    1277229 QUATTRO LINK ANCHOR 4.5MM SP FASTENER, FIXATION MBI CAYENNE MEDICAL N/A 78365-3 00887868270208

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O