BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 3093523 · Received May 6, 2013

    Report

    Report Number
    0001811755-2013-01027
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (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. THE ATTACHMENT IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL INFORMATION WAS REPORTED BY THE USER FACILITY, THAT THE PIECE OF BROKEN BUR DID NOT ENTER THE SURGICAL SITE AND THAT THERE WAS NO REPORT OF HARM TO ANYONE. IT WAS ALSO REPORTED THAT A BACKUP DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, A BUR BROKE IN THE ATTACHMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 A SURGICAL PROCEDURE AT THE USER FACILITY, A BUR BROKE IN THE ATTACHMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. THE ADDITIONAL INFORMATION WAS REPORTED BY THE USER FACILITY, THAT THE PIECE OF BROKEN BUR DID NOT ENTER THE SURGICAL SITE AND THAT THERE WAS NO REPORT OF HARM TO ANYONE. IT WAS ALSO REPORTED THAT A BACKUP DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, A BUR BROKE IN THE ATTACHMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. THE ADDITIONAL INFORMATION WAS REPORTED BY THE USER FACILITY, THAT THE PIECE OF BROKEN BUR DID NOT ENTER THE SURGICAL SITE AND THAT THERE WAS NO REPORT OF HARM TO ANYONE. IT WAS ALSO REPORTED THAT A BACKUP DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197272 SD/PD LONG CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 12308

    Patients

    Seq Age Sex Outcome Treatment
    1 8420107025 CURVED BUR, LOT UNKNOWN