BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 2140620 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02200
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER, AND THE COMPLAINT WAS CONFIRMED. BASED ON THE DEVICE EVALUATION, A BROKEN BUR WAS CONFIRMED WITHIN THE DRILL ATTACHMENT. THE CAUSE OF THE BUR BREAKAGE IS UNKNOWN. THE DEVICE 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 CONDUCTED PRIOR TO THE START OF A SURGICAL PROCEDURE, A BUR BROKE WITHIN THE DRILL ATTACHMENT. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT 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 SD/PD MEDIUM CURVED ERL STRYKER INSTRUMENTS KALAMAZOO 10133

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK