BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORATOR BIT LARGE 14/11MM

    MDR report key: 2990848 · Received March 6, 2013

    Report

    Report Number
    0001811755-2013-00454
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBF
    PMA / PMN Number
    K082010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORATOR BIT SUBJECT TO THIS MDR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS WAITING ON FUNCTIONAL TESTING. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. ON COMPLETION OF THE TESTING, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE PERFORATOR BIT SUBJECT TO THIS MDR WAS RETURNED FOR EVALUATION. FUNCTION TESTING OF THE RETURNED DEVICE WAS PERFORMED. NO ATYPICAL RESULTS WERE NOTED DURING REPLICATION CUT TESTING. THE PERFORATOR BIT FUNCTIONED AS INTENDED IN ALL CASES. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE THE PERFORATOR BIT DID NOT DISENGAGE. IT WAS ALSO REPORTED THAT THE PERFORATOR BIT TORE THE DURA AND THERE WAS SOME BLEEDING AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIAL PROCEDURE THE PERFORATOR BIT DID NOT DISENGAGE. IT WAS ALSO REPORTED THAT THE PERFORATOR BIT TORE THE DURA AND THERE WAS SOME BLEEDING AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95600 PERFORATOR BIT LARGE 14/11MM DRILLS, BURRS, TREPHINES & ACCESSORIES HBF STRYKER INSTRUMENTS-KALAMAZOO 13017027

    Patients

    Seq Age Sex Outcome Treatment
    1