BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAPHIC CASE FOR VEPTR II ROD INSTRUMENTS

    MDR report key: 3023279 · Received March 27, 2013

    Report

    Report Number
    3003787298-2013-10056
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    April 23, 2012
    Report Date
    April 23, 2012
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING INVESTIGATION AND APPEARED TO BE SEVERELY DAMAGED. EVERY COMPONENT WAS BENT, DEFORMED, OR COMPROMISED FROM ACTIONS IN THE FIELD. ALL NYLON BRACKETS LOCATED ON THE BASE PLATE ASSEMBLY TRAY ASSEMBLY WERE BENT, DAMAGED, OR DEFORMED IN SOME MANNER. THE LID AND BASE ASSEMBLY WERE SEVERELY BENT OR DAMAGED. DUE TO THE RECEIVED CONDITION, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS CONCERNED THAT THE INSTRUMENTS IN THE VEPTR II GRAPHIC CASES COULD NOT BE PROPERLY STERILIZED BECAUSE THE PLASTIC COATING WAS PEELING OFF THE METAL. ACCOUNT WAS CONCERNED THAT DEBRIS COULD GET IN THE CREVICES BETWEEN THE PLASTIC AND METAL, CONTAMINATING THE INSTRUMENTS. THIS IS REPORT 4 OF 6 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 6 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125108 GRAPHIC CASE FOR VEPTR II ROD INSTRUMENTS FSM SYNTHES JENNERSVILLE 5649265

    Patients

    Seq Age Sex Outcome Treatment
    1