BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXFIRE MARXMEN CURVED CURVED

    MDR report key: 7044519 · Received November 20, 2017

    Report

    Report Number
    0001825034-2017-10123
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    October 23, 2017
    Report Date
    December 20, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    PK061776
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. AS RETURNED THE INSERTER OF THE DEVICE WAS BENT AND SUTURE CAN BE SEEN IN THE INSERTER. THE GUN DID NOT SHOW ANY DAMAGE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 900320, MAXFIRE MARXMEN STRAIGHT, 384740. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(4). 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 - 2017 - 10124.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE INSERTERS BENT DURING USE INSIDE OF THE PATIENT'S BODY. THEREFORE, THE SURGEON USED ALTERNATIVE PRODUCTS TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826158 MAXFIRE MARXMEN CURVED CURVED STAPLE, FIXATION HWC ZIMMER BIOMET, INC. N/A 680880

    Patients

    Seq Age Sex Outcome Treatment
    1