BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIOLUCENT DRIVE DRILL BIT

    MDR report key: 2962866 · Received February 15, 2013

    Report

    Report Number
    0001811755-2013-00281
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL BIT SUBJECT TO THIS INVESTIGATION WAS RETURNED TO THE MANUFACTURER FOR EVALUATION, IT WAS VISUALLY CONFIRMED THE DRILL BIT WAS BROKEN AT THE BASE AND AT THE TIP OF THE BIT. MANUFACTURING RECORDS WERE REVIEWED, NO ISSUES WERE IDENTIFIED WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A T2 TIBIA SURGERY PROCEDURE, THE BASE OF THE DRILL BIT BROKE. IT WAS ALSO REPORTED THAT TIP OF DRILL STUCK IN THE BONE; THE SURGEON SHAVED A LITTLE CORTICAL BONE, IN ORDER TO REMOVE BROKEN DRILL TIP FROM THE BONE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66193 RADIOLUCENT DRIVE DRILL BIT SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS HRX STRYKER INSTRUMENTS-KALAMAZOO 12262017

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention