BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN BUR

    MDR report key: 1945891 · Received December 28, 2010

    Report

    Report Number
    9616696-2010-00383
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    STRYKER INSTRUMENTS CORK
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUR WILL NOT BE RETURNED TO THE MFR FOR TESTING, SO AN EVAL OF THE DEVICE IS NOT POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BUR BROKE DURING A ROUTINE MAINTENANCE VISIT AT THE ACCOUNT AND IN A NON-STERILE ENVIRONMENT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BUR SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC HBE STRYKER INSTRUMENTS CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK