BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U-SERIES MEDIUM CURVED

    MDR report key: 3092179 · Received May 3, 2013

    Report

    Report Number
    0001811755-2013-01019
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 22, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    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 WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.THE USER FACILITY PROVIDED THE ADDITIONAL INFORMATION THAT THE BROKEN BUR DID FALL INTO THE SURGICAL SITE, BUT WAS SUCCESSFULLY REMOVED BECAUSE THE SURGEON COULD SEE IT EASILY THROUGH THE SCOPE HE WAS USING AND THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    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 WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    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 WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THE USER FACILITY PROVIDED THE ADDITIONAL INFORMATION THAT THE BROKEN BUR DID FALL INTO THE SURGICAL SITE, BUT WAS SUCCESSFULLY REMOVED BECAUSE THE SURGEON COULD SEE IT EASILY THROUGH THE SCOPE HE WAS USING AND THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194776 U-SERIES MEDIUM CURVED MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO 11305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BUR