BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 3MM

    MDR report key: 6029641 · Received October 14, 2016

    Report

    Report Number
    2523190-2016-00179
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Report Date
    September 16, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HAE
    PMA / PMN Number
    K150428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    10/17/16 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - FAILURE ANALYSIS CANNOT BE PERFORMED BASED ON THE LACK OF INFORMATION PROVIDED BY THE CUSTOMER. THE RONGEURS WERE NOT RETURNED FOR FURTHER EVALUATION. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. THE RONGEURS WERE NOT RETURNED FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS SCREWS FELL OUT OF 2 KERRISONS. DOCTORS ARE COMPLAINING THEY ARE NOT SHARP, THEY ARE NOT CUTTING, THEY ARE TEARING. ON (B)(6) 2016 NO HARM DONE. ON 9/30/16 CUSTOMER REPORTS SHE HAS NO SPECIFIC INFORMATION FOR AN EVENT EXCEPT ONE OF THE SCREWS DID FALL INTO A PATIENT WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682454 ULTRA-COAT MICRO EJECT KERRISON 40D UP 8 3MM ULTRA-COAT HAE INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1