BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHOTON-TYPE HOOK 71/2 90D SSHP

    MDR report key: 5062384 · Received September 8, 2015

    Report

    Report Number
    2523190-2015-00075
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    February 27, 2015
    Report Date
    August 24, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - THERE IS ONE RHOTON-TYPE HOOK RETURNED IN USED CONDITION, SHOWING MINIMAL WEAR. INSPECTED THE HOOK AND THE TIP IS BROKEN OFF, THIS IS A VERY DELICATE INSTRUMENT AND COULD HAVE HAPPENED WHILE IN USE OR EVEN DROPPED. THIS COMPLAINT IS CONFIRMED/ROOT CAUSE UNDETERMINED. 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: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS SURGEON WAS PERFORMING AN ANTERIOR CERVICAL FUSION. HE NOTICED THAT THE INSTRUMENT (A RHOTON DISSECTOR) WAS MISSING A PART OF ITS TIP. X-RAY TAKEN AT END OF PROCEDURE WAS NEGATIVE FOR PRESENCE OF FOREIGN BODY IN THE INCISION SITE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592687 RHOTON-TYPE HOOK 71/2 90D SSHP N/A GZX INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR