BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE MARXMEN CURVED CURVED

    MDR report key: 10307454 · Received July 22, 2020

    Report

    Report Number
    0001825034-2020-02849
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 14, 2020
    Report Date
    November 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K111564
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED ONE SET OF ANCHORS WAS RETURNED AS SEEN IN THE PHOTOS MARKED ANCHORS. ONE SMALL PIECE OF A SUTURE WAS BROKEN AS SEEN IN THE PHOTO MARKED BROKEN SUTURE. ITEM AND LOT NUMBERS ARE NOT CONFIRMED AS THEY ARE NOT ETCHED ON THE PARTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: 900321 MAXFIRE MARXMEN CURVED CURVED 159240. 900320 MAXFIRE MARXMEN STRAIGHT 667710. REPORT SOURCE: (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-02848, 0001825034-2020-02850.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALL-SUTURE IMPLANT PULLED OUT WHILE IMPLANTING DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774216 MAXFIRE MARXMEN CURVED CURVED FASTENER, FIXATION MBI ZIMMER BIOMET, INC. 159240

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR