BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD-CLAMP F/MEF

    MDR report key: 3184952 · Received June 24, 2013

    Report

    Report Number
    8030965-2013-03355
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    April 27, 2011
    Report Date
    May 23, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION SHOWED THAT THE HOLDING GROOVES ARE SLIGHTLY DAMAGED AND WORN. A CORRECT SEATING OF THE TUBE CANNOT BE GUARANTEED ANYMORE. THE DAMAGES INDICATE THAT THE TUBES MAY HAVE NOT BEEN PLACED ACCORDINGLY AND CAUSED THESE DAMAGES ON THE HOLDING GROOVES. THERE WAS NOTHING WRONG WITH THE FUNCTION OF THE CLAMP ITSELF. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WHERE FOUND. NO PRODUCT FAULT COULD BE DETECTED. THIS COMPLAINT IS INVALID FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLAMP IS BROKEN. IT DOES NOT HOLD THE TUBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286683 STD-CLAMP F/MEF LXH SYNTHES GMBH 3332552

    Patients

    Seq Age Sex Outcome Treatment
    1