BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORATOR BIT LARGE 14/11MM

    MDR report key: 3205402 · Received July 3, 2013

    Report

    Report Number
    0001811755-2013-01588
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBF
    PMA / PMN Number
    K082010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART WAS RETURNED, AND IT WAS CONFIRMED TO PERFORM AS EXPECTED. THE DEFINITE ROOT CAUSE OF THIS ISSUE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING AND A FOLLOW UP WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFORATOR BIT 14/11MM DID NOT STOP SPINNING DURING A PROCEDURE. THE PERFORATOR BIT PLUNGED AND TORE THE DURA, AS A RESULT THERE WAS A DURA LEAK WHEN THEY PULLED BACK. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROCEDURE DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFORATOR BIT 14/11MM DID NOT STOP SPINNING DURING A PROCEDURE. THE PERFORATOR BIT PLUNGED AND TORE THE DURA, AS A RESULT THERE WAS A DURA LEAK WHEN THEY PULLED BACK. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROCEDURE DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304360 PERFORATOR BIT LARGE 14/11MM DRILLS, BURRS, TREPHINES & ACCESSORIES HBF STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other