BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTINE TRIPLE

    MDR report key: 857523 · Received May 18, 2007

    Report

    Report Number
    3003644133-2007-00002
    Event Type
    Injury
    Date Received
    May 18, 2007
    Date of Event
    April 18, 2007
    Report Date
    April 18, 2007
    Manufacturer
    COAPT SYSTEMS, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COAPT SYSTEMS, INC. HAS REC'D ONE ENDOTINE TRIPLE DEVICE INVOLVED IN THE CASE. THE OTHER DEVICE INVOLVED WAS DISCARDED BY THE SITE. COAPT IS CURRENTLY INVESTIGATING THE DEVICE. A CONCLUSION CAN NOT BE MADE AT THIS TIME SINCE THE INVESTIGATION HAS NOT YET BEEN COMPLETED. A SUPPLEMENTAL MDR REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DOCTOR HAD A CASE INVOLVING TWO ENDOTINE TRIPLE DEVICES. DOCTOR SUCCESSFULLY ENGAGED TWO TRIPLE DEVICES INTO THE DRILLED HOLES, HOWEVER, ALL THE TINES OF BOTH DEVICES BROKE OFF WHEN THE DOCTOR ATTEMPTED TO ENGAGE THE TISSUE WITH THEM. THE PHYSICIAN INVOLVED WAS CONCERNED ABOUT THE DRILLED HOLES AND THE TECHNIQUE HE WAS USING TO DRILL THEM. THE DOCTOR DRILLED FOUR HOLES IN ORDER TO PREPARE HOLES THAT WOULD SECURELY HOLD THE DEVICES IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTINE TRIPLE SMOOTH METALLIC BONE FIXATION FASTNER HWC COAPT SYSTEMS, INC. CFD-010-0167 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention