BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 3062314 · Received April 16, 2013

    Report

    Report Number
    0001811755-2013-00813
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORTING OF THE EVENT REPORTED ON ASR ID (B)(4).

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, IT WAS CONFIRMED THAT A BUR HAD BROKEN INSIDE THE ATTACHMENT. THE BUR BREAKING COULD POTENTIALLY HAVE BEEN CAUSED BY A NUMBER OF FACTORS INCLUDING USER APPLIED SIDE LOADING, BUR EXPOSURE, RUNNING SPEED AS WELL AS ATTACHMENT AND DRILL CONDITIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP FOR A SURGICAL PROCEDURE AT THE USER FACILITY THE BUR BROKE OFF IN THE ATTACHMENT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP FOR A SURGICAL PROCEDURE AT THE USER FACILITY THE BUR BROKE OFF IN THE ATTACHMENT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163824 SD/PD LONG CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 12258

    Patients

    Seq Age Sex Outcome Treatment
    1 MIS PRECISION NEURO BUR CATALOG 842010753