BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PECTUS TABLE TOP BENDER

    MDR report key: 7044927 · Received November 20, 2017

    Report

    Report Number
    0001032347-2017-00808
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    April 24, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HXW
    PMA / PMN Number
    PK972420
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    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. THE INSTRUMENT WAS VISUALLY EVALUATED AND FOUND TO BE IN DECENT OVERALL CONDITION. THERE WERE SCRATCHES AND SIGNS OF WEAR ON THE INSTRUMENT; NO DISCOLORATION WAS OBSERVED. THE INTERNAL COMPONENTS WERE ROTATED INSIDE THE ASSEMBLY, RESULTING IN GALLING ON THE HANDLE CAM AND PLUNGER WHEEL WHERE THE SURFACES COME IN CONTACT AND CAUSING FRICTION DURING HANDLE ACTUATION. THE COMPLAINT WAS CONFIRMED AS THE INTERNAL ROLLER MECHANISM IS ROTATED OUT OF PLACE, CAUSING DAMAGE TO THE CAM AND WHEEL AND HINDERING ACTUATION OF THE LEVER ARM. MANUFACTURING HISTORY WAS REVIEWED AND NO NON-CONFORMANCE WAS IDENTIFIED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO EXCESSIVE FORCE. 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION AND/OR COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TABLE TOP BENDER DOES NOT FUNCTION PROPERLY. MORE INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826178 PECTUS TABLE TOP BENDER PECTUS BAR BENDER HXW BIOMET MICROFIXATION N/A 061014E14

    Patients

    Seq Age Sex Outcome Treatment
    1