BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-LINK-CLAMP F/R Ø6 PREASSMBL TAN DB

    MDR report key: 3171639 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02910
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    October 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    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. THE INVESTIGATION OF THE COMPLAINED PREASSEMBLED USS CROSS-LINK CLAMPS SHOW THAT ONE INNER PART WAS NOT ASSEMBLED ACCORDINGLY. THE EXACT CAUSE FOR THIS PROBLEM IS UNDETERMINED, THE REPORTED ISSUE REVEALS THAT IT IS POSSIBLE ONE STEP DURING THE MANUFACTURING PROCESS WAS NOT CARRIED OUT PROPERLY. THIS IS CONSIDERED A MANUFACTURING FAULT. IT IS PRESUMED THESE PARTICULAR ARTICLES WERE INADVERTENTLY PACKED WITHOUT HAVING GONE THROUGH PROPER CONTROL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS DEEMED VALID, A CAPA DETERMINATION REQUEST HAS BEEN INITIATED.

    Description of Event or Problem · 1

    THE CLAMPS SEEMED TO BE JAMMED OR BLOCKED. THE CLAMPS WERE NOT USEFUL DURING THE OPERATION. THIS IS 1 OF 17 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272630 CROSS-LINK-CLAMP F/R Ø6 PREASSMBL TAN DB NKB SYNTHES GMBH 2781162

    Patients

    Seq Age Sex Outcome Treatment
    1