BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRO LINK SP KNOTLESS ANCHOR 4.5MM PEEK ANCHOR WITH TITANIUM TIP

    MDR report key: 19226888 · Received May 1, 2024

    Report

    Report Number
    3006108336-2024-00014
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 15, 2024
    Report Date
    October 22, 2024
    Manufacturer
    CAYENNE MEDICAL
    Product Code
    MBI
    PMA / PMN Number
    K122314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE LOTS WERE REPORTED WITH THIS EVENT BUT ONLY ONE FRACTURED ANCHOR WAS PICTURED. POSSIBLE LOTS ARE NOTED BELOW FOR THE ANCHOR THAT WAS PICTURED FRACTURED. POSSIBLE LOTS: D4: LOT: 66321381. D4: UDI: (B)(4). H4: MAN: OCT 24, 2023. D4: EXP: OCT 24, 2028. D4: LOT: 66224175. D4: UDI: (B)(4). H4: MAN: OCT 6, 2023. D4: EXP: OCT 6, 2028. D4: LOT: 65390589. D4: UDI: (B)(4). H4: MAN: FEB 7, 2022. D4: EXP: FEB 7, 2027. D10: PART: 902612. 5.0MM ALLTHREAD TI III BLACK/B. LOT: 0002513658. PART: 902612. 5.0MM ALLTHREAD TI III BLACK/B. LOT: 0002488305. PART: 902591. 5.0 ALLTHREAD TI 2#2 MB. LOT: 0002521395. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: A1; H2; H3; H6. THE REPORTED EVENT IS CONFIRMED FROM PROVIDED PICTURES. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED ANCHOR BODY IS FRACTURED NEAR EYELET HOLE. AS NO PRODUCT WAS RETURNED OR FURTHER PICTURES PROVIDED; 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 THAT THERE WAS AN UNKNOWN ISSUE WITH TWO IMPLANTS. A PICTURE WAS PROVIDED, AND THE METAL TIP ANCHOR IS FRACTURED. HOWEVER, IT CANNOT BE CONFIRMED WHICH ANCHOR FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED BASED ON AVAILABLE INFORMATION PROVIDED. 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
    456900 QUATTRO LINK SP KNOTLESS ANCHOR 4.5MM PEEK ANCHOR WITH TITANIUM TIP FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI CAYENNE MEDICAL N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown