BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED SABER PORTMAN CHUCK

    MDR report key: 2132288 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02086
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RECEIVED BY THE MFR AND THE COMPLAINT WAS CONFIRMED. DURING THE DEVICE EVAL, THE DRILL ATTACHMENT OPERATED VERY ROUGH, INDICATING POSSIBLE CONTAMINATION WITHIN INTERNAL COMPONENTS. THE DRILL ATTACHMENT COULD NOT BE REPAIRED AND THEREFORE, WAS NOT RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EQUIPMENT TESTING, 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 ANGLED SABER PORTMAN CHUCK ERL STRYKER INSTRUMENTS KALAMAZOO 05265

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK