BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAPHIC CASE FOR VEPTR II INSTRUMENTS

    MDR report key: 3023281 · Received March 27, 2013

    Report

    Report Number
    3003787298-2013-10055
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    April 23, 2012
    Report Date
    April 23, 2012
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    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 EXTREMELY USED WITH SCRATCHES AND DAMAGE TO THE LID AND THE EXTERIOR OF THE BASE ASSEMBLY. THE ANODIC COATING OF THE TRAYS WAS DISCOLORED AND STAINED FROM MULTIPLE CLEANING AND STERILIZATION CYCLES. THE NYLON COATED BRACKETS INSTALLED ON BOTH TRAY ASSEMBLIES WERE SEVERELY DEFORMED AND BENT WITH AREAS OF THE NYLON COATING COMPROMISED FROM DAMAGE (SCRAPED OFF). THE DAMAGE NOTED TO THE NYLON BRACKETS IS EVIDENCE OF CONTACT DAMAGE AND NOT FROM PEELING OR DELAMINATION. DUE TO THE RECEIVED CONDITION AND UNKNOWN STERILIZATION ENVIRONMENTS THAT THE UNIT WAS SUBJECTED TO IN THE FIELD, 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. (B)(4).

    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 3 OF 6 FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 6 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127039 GRAPHIC CASE FOR VEPTR II INSTRUMENTS LXH SYNTHES JENNERSVILLE 6431088

    Patients

    Seq Age Sex Outcome Treatment
    1