BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRA LONG ANGLED SABER ATTACHMENT

    MDR report key: 2233182 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02660
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND AN INVESTIGATION IS ANTICIPATED. A F/U REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL ATTACHMENT HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRA LONG ANGLED SABER ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK