BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARGIS CORONOID CLAMP

    MDR report key: 6459420 · Received April 5, 2017

    Report

    Report Number
    0001032347-2017-00257
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Report Date
    April 3, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GDJ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. PHOTOGRAPHS WERE PROVIDED WHICH CONFIRM THE INSTRUMENT IS BROKEN. 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 GDJ.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSTRUMENT BROKE DURING SURGERY. THE BROKEN PIECE DID NOT FALL INTO THE PATIENT AND THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY AS A RESULT OF THIS EVENT. A BACK-UP INSTRUMENT WAS AVAILABLE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244011 HARGIS CORONOID CLAMP CLAMP, MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GDJ BIOMET MICROFIXATION N/A 984260

    Patients

    Seq Age Sex Outcome Treatment
    1