BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U2 DRILL

    MDR report key: 2130138 · Received May 5, 2011

    Report

    Report Number
    1811755-2011-01609
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RETURNED TO THE MFR; HOWEVER, THE PRODUCT HAS YET TO BE EVALUATED. A F/U REPORT WILL BE FILED ONCE THE PRODUCT EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL HEATED UP AFTER THE SURGICAL PROCEDURE. THERE WAS NO USER INJURY REPORTED, AND NO OTHER ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U2 DRILL ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK