BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BENDING PLIERS

    MDR report key: 2962942 · Received February 15, 2013

    Report

    Report Number
    8030965-2013-00466
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO NON CONFORMITIES WERE FOUND. THE RETURNED DEVICE WAS MANUFACTURED IN SEPTEMBER 2007 AND IS OVER 5 YEARS OLD. THE DEVICE SHOWS EVIDENCE OF EXTENSIVE USE AND WEAR. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE PLIERS ARE MANUFACTURED FROM 420A MATERIAL WITH A CARBIDE INSERT WHICH IS A TYPICAL MATERIAL COMBINATION USED TO MANUFACTURE UNIVERSAL BENDING PLIERS. THE DEVICE IS ALSO HEAT TREATED TO IMPROVE WEAR PROPERTIES. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED DEVICE IS OVER 5 YEARS OLD AND SHOWS EVIDENCE OF EXTENSIVE WEAR.

    Description of Event or Problem · 1

    STERILE PROCESSING DEPARTMENT WAS GOING THRU THE SETS AFTER CLEANING AND NOTICED AN INSTRUMENT WAS BROKEN. ONE OF THE TIPS ON THE BENDER HAS BROKEN OFF, LOOKS RUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68055 UNIVERSAL BENDING PLIERS UNIVERSAL BENDING PLIERS LXH SYNTHES GMBH A7QA35

    Patients

    Seq Age Sex Outcome Treatment
    1