BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO LINK ANCHOR 4.5MM

    MDR report key: 16019481 · Received December 20, 2022

    Report

    Report Number
    3006108336-2022-00036
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    August 23, 2022
    Report Date
    March 31, 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
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3006108336 - 2022 -0041. CONCOMITANT MEDICAL PRODUCTS: PART # CM-9324, ST 2.9MM GL HARD BONE DRILL ,LOT # 65415347, QTY 1; PART # CM-9145, QUATTRO LINK ANCHOR 4.5MM, LOT # 81553-2, QTY 1; PART # CM-9155, QUATTRO LINK ANCHOR 5.5MM, LOT # 67346-3, QTY 2; PART # CM-9145, QUATTRO LINK ANCHOR 4.5MM, LOT # 65415424, QTY 2; PART # CM-9155, QUATTRO LINK ANCHOR 5.5MM, LOT # 67346-3, QTY 1. PRODUCTS HAVE BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. 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. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE BENT 'CLEATS'. BOTH DEVICES INSERTER PRONGS ARE BENT AT ROUGHLY 45 DEGREES, AND ONE HAS THE PRONGS PUSHED TOGETHER. THE INSERTERS¿ ADJUSTMENT KNOBS AND TRIGGER MECHANISMS FUNCTION SMOOTHLY AND EXTEND AND RETRACT THE INSERTER SHAFT. IT IS NOTED THAT THE ANCHOR WAS NOT RETURNED FOR EVALUATION. 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. CORRECTED, EVENT IS NO LONGER REPORTABLE; NO SERIOUS INJURY OR HARM TO THE PATIENT REPORTED FOR THIS EVENT OR PRIOR EVENTS WITH SAME OR SIMILAR PRODUCTS. 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 DURING SURGERY THAT TWO ANCHORS WERE BENT AND NOT DISENGAGING PROPERLY. 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
    457347 QUATTRO LINK ANCHOR 4.5MM FASTENER, FIXATION MBI CAYENNE MEDICAL N/A 65415424 00887868270192

    Patients

    Seq Age Sex Outcome Treatment
    1 Female SEE H10