BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKX LOCKCAP F/498.571 TAN

    MDR report key: 3171590 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02859
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    October 13, 2011
    Report Date
    November 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (B)(6). THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE HEXAGON RECESS OF THE SET SCREW COULD NOT BE MEASURED AS THEY ARE COMPLETELY STRIPPED. THE STRIPPED HEXAGON RECESS INDICATES THAT EXCESSIVE FORCES WERE APPLIED ONTO THESE LOCKING CAPS. THE CAUSE IS UNKNOWN.

    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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS NOTED ON (B)(6) 2011 THAT THE SCREW TABS SNAPPED OFF IN THE L HANDLE OF TWO LOCKING CAPS. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272443 CLICKX LOCKCAP F/498.571 TAN MNH SYNTHES GMBH 7636425

    Patients

    Seq Age Sex Outcome Treatment
    1