BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 1850999 · Received September 23, 2010

    Report

    Report Number
    1811755-2010-01243
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS CONFIRMED. THE DEVICE WAS DISASSEMBLED, AND CORROSION AND DEBRIS WERE FOUND INSIDE. BASED ON THE INVESTIGATION DETAILS, THE FAILURE OF THE ATTACHMENT WAS MOST LIKELY CAUSED BY CORROSION AND DEBRIS PRESENT ON ASSEMBLY COMPONENTS, INCLUDING BEARINGS. THIS WAS LIKELY THE RESULT OF INADEQUATE CLEANING BY NOT FOLLOWING THE INSTRUCTIONS FOR USE. THE ATTACHMENT WAS SCRAPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTACHMENT BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THE CASE WAS CONTINUED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC ERL STRYKER INSTRUMENTS KALAMAZOO 08350

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK