BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 9215805 · Received October 21, 2019

    Report

    Report Number
    0001032347-2019-00465
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    UDI-DI
    00841036011239
    PMA / PMN Number
    K972420
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE CUSTOMER REPORTED THAT THEIR 01-3906 PECTUS TABLE TOP BENDER ARM IS REALLY STIFF. FUNCTIONAL TESTING AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE PRODUCT NOT BEING RETURNED. A DETERMINATION COULD NOT BE MADE OFF OF THE CUSTOMER PROVIDED PHOTOGRAPH. FOR THESE REASONS, THE COMPLAINT CANNOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. FOR THIS PART (01-3906) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE), THERE HAS BEEN A COMPLAINT RATE OF 2.4%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (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.  THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE ¿ (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PECTUS BENDER MALFUNCTIONED DURING SURGERY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009597 PECTUS TABLE TOP BENDER BENDER HXW BIOMET MICROFIXATION N/A N/A 00841036011239

    Patients

    Seq Age Sex Outcome Treatment
    1