BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO LINK ANCHOR 2.9MM

    MDR report key: 15750943 · Received November 8, 2022

    Report

    Report Number
    3006108336-2022-00033
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    October 12, 2022
    Report Date
    January 5, 2023
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    MBI
    UDI-DI
    00887868270161
    PMA / PMN Number
    K122314
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART # CM-9145SP QUATTRO LINK ANCHOR 4.5MM SP LOT # 65472625. PART # CM-9129 QUATTRO LINK ANCHOR 2.9MM LOT # 65319443, PART # CM-9300ST 2.9MM GL DRILL LOT # 65354710, PART # CM-0322 BRDBAND 2PK:BK/BL+BK LOT # 20072125, PART # 904055 EZ PASS 30 DEGREE RIGHT LOT # 489880, PART # 904055 EZ PASS 30 DEGREE RIGHT LOT # 417750, PART # CM-9255BG QUATTRO X ANCHOR 5.5 BB TAPENS LOT # 78826-2, PART # CM-0322 BRDBAND 2PK:BK/BL+BK LOT # 21090124, PART # CM-9011 QUATTRO SUTURE PASSER NEEDLE LOT # 65223488, PART # CM-9145SP QUATTRO LINK ANCHOR 4.5MM SP LOT # 65390524. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO LOCATION OF DEVICE IS UNKNOWN. 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 PROVIDED PICTURES SHOW THAT THE ANCHOR IS FRACTURED AT THE INDICATOR LINE AND REMAINS IN PLACE AT THE TIP OF THE INSERTER. THE OTHER BROKEN PORTION OF THE ANCHOR CANNOT BE SEEN IN THE PROVIDED PHOTOS. THE INSERTER PRONGS ARE ALSO BENT AT THE TIP. AS NO DEVICE WAS RETURNED, FURTHER 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. 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 ON THE RIGHT SIDE OF THE PATIENT, WHILE MALLEATING IN THE ANCHOR, THE TIP OF THE ANCHOR BROKE IN HALF. ANCHOR WAS REMOVED AND ADDITIONAL ANCHOR WAS USED TO COMPLETE THE PROCEDURE. 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
    2228527 QUATTRO LINK ANCHOR 2.9MM FASTENER, FIXATION MBI CAYENNE MEDICAL N/A 65319443 00887868270161

    Patients

    Seq Age Sex Outcome Treatment
    1 Male SEE H10