BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 2082066 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01339
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 FOUND WITHIN THE DRILL ATTACHMENT. THE DEVICE COULD NOT BE REPAIRED AND THEREFORE WAS NOT RETURNED TO THE USER FACILITY. A FOLLOW UP REPORT WILL BE SUBMITTED IF FURTHER INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CLEANING PROCESS, A BUR BROKE WHILE INSIDE 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 LONG CURVED ERL STRYKER INSTRUMENTS KALAMAZOO 09247

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK