BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IQ DRIVER

    MDR report key: 6064011 · Received October 28, 2016

    Report

    Report Number
    0001032347-2016-00628
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    August 26, 2016
    Report Date
    September 29, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0001032347-2016-00627.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. DEVICE PRODUCT CODE: GEY. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 0001032347-2016-00627.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS THAT TWO 1.4MM IQ DRILLS CAME OFF FROM THE COLLET OF AN IQ DRIVER. THE DRIVER WAS FUNCTIONALLY TESTED USING A KNOWN WORKING BATTERY (72-1010), A DRILL BIT (72-2053), AND A BLADE (72-3001). THE BITS COULD EASILY BE ROTATED OUT OF THE DRIVER WHEN IN THE LOCKED POSITION. THE MOST LIKELY CAUSE OF THE COMPLAINT WAS A FAILURE OF THE COLLET ON THE IQ DRIVER. THE TWO RETURNED DRILLS WERE FOUND TO FUNCTION AS INTENDED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. SUPPLEMENTAL REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2016-00627-2.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE CLOSING A CRANIOTOMY THE TWIST DRILL CAME OUT OF THE DRIVER WHEN INSERTED INTO THE PATIENT'S BONE. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY. THE SURGERY WAS COMPLETED USING ANOTHER DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715927 IQ DRIVER IQ DRIVER HWC BIOMET MICROFIXATION N/A 5I0180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention