BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD-CLAMP F/MEF

    MDR report key: 3188426 · Received June 25, 2013

    Report

    Report Number
    8030965-2013-03212
    Event Type
    Malfunction
    Date Received
    June 25, 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

    ADDITIONAL NARRATIVE: 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION SHOWED THAT THE HOLDING GROOVES WERE WORN OUT; THEREFORE, A CORRECT SEATING OF THE TUBE COULD NOT BE GUARANTEED ANYMORE. IT SHOULD BE NOTED THAT THE CLAMP HAS BEEN IN USE FOR SEVERAL YEARS. IT IS POSSIBLE THAT THE DAMAGES WERE CAUSED BY NORMAL WEAR AND TEAR. NO PRODUCT FAULT COULD BE DETECTED. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLAMP WAS WORN AND WOULDN'T HOLD THE TUBE. AFTER FEW MINUTES, THE CLAMP LET GO OF THE TUBE. THIS HAPPENED A FEW TIMES. THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288414 STD-CLAMP F/MEF LXH SYNTHES GMBH 1704050

    Patients

    Seq Age Sex Outcome Treatment
    1