BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTECHMENT

    MDR report key: 2369320 · Received November 7, 2011

    Report

    Report Number
    1811755-2011-04022
    Event Type
    Malfunction
    Date Received
    November 7, 2011
    Date of Event
    October 12, 2011
    Report Date
    October 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING THE UNIT AT THE USER FACILITY PRIOR TO A PROCEDURE, THE ATTACHMENT HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. THERE WAS NO USER INJURY REPORTED AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO DRILL MEDIUM STRAIGHT ATTECHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 11152

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK