BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 2233194 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02654
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE BUR HAD BROKEN JUST BELOW THE HEAD OF THE UNIT. THE DEVICE WAS REASSEMBLED AND A NEW BUR WAS ABLE TO BE LOADED AND UNLOADED IN THE ATTACHMENT. THEN A CUT TEST WAS PERFORMED AND THE TEST BUR DID NOT FRACTURE. THE CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. IT IS POSSIBLE THE BUR BROKE DUE TO AGGRESSIVE SIDE LOADS OR CHATTER WHILE CUTTING. THE DHR REVIEW INDICATED THE DEVICE PASSED ALL TESTING AND INSPECTIONS AS REQUIRED AT THE TIME OF MFR. THERE WERE NO RELEVANT NON-CONFORMANCE RECORDS ASSOCIATED WITH THE RELEASE OF THE DEVICE. THERE WERE NO RELEVANT NON-CONFORMANCES, ALERTS, DEVIATIONS, OR REWORK RELATED TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR HEAD BROKE OFF IN THE ATTACHMENT. THIS DISCOVERED THIS WHEN TRYING TO REMOVE THE BUR AFTER A PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SD/PD MEDIUM CURVED ERL STRYKER INSTRUMENTS KALAMAZOO 10281

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK