BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOMPRESSOR MINI COMPRESSION DRIVER

    MDR report key: 1297969 · Received December 9, 2008

    Report

    Report Number
    3004608878-2008-00102
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    November 18, 2008
    Report Date
    December 9, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED, BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A KOMPRESSOR SCREW WAS BEING PLACED IN A FIRST METATARSAL WHEN THE TIP OF THE TRAILING DRIVER COLLAPSED ON ITSELF, AND A PIECE ABOUT 1MM X 1MM BROKE OFF INTO THE PT'S SURGICAL WOUND. RADIOGRAPHS WERE DONE AND THE FRAGMENT WAS RETRIEVED. IT WAS DECIDED TO LEAVE THE SCREW HEAD IN THE BONE, SEATED 2MM PROUD. THE SCREW HEAD WAS NOT REMOVED OR COUNTERSUNK MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOMPRESSOR MINI COMPRESSION DRIVER UPPER EXTREMITY COMPRESSION SCREW DRIVER HWC INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention