BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP NITINOL NDL SINGLE PACK

    MDR report key: 6913567 · Received October 4, 2017

    Report

    Report Number
    0001825034-2017-07877
    Event Type
    Malfunction
    Date Received
    October 4, 2017
    Date of Event
    August 12, 2014
    Report Date
    October 3, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HXO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    DURING THE PROCEDURE, TWO SUTURES WERE SUCCESSFULLY PASSED, BUT THE NITINOL NEEDLE FRACTURED INSIDE THE MAMBA SUTURE PASSER WHEN THE THIRD SUTURE WAS PASSED. A BIPASS SUTURE PASSER WAS USED TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693534 DISP NITINOL NDL SINGLE PACK SPORTS MED INSTRUMENTATION HXO ZIMMER BIOMET, INC. N/A 139820

    Patients

    Seq Age Sex Outcome Treatment
    1