BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-SCR Ø12.5 L105 SST

    MDR report key: 3171656 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02999
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    May 29, 2012
    Report Date
    May 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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). MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. MANUFACTURED ACCORDING TO SPECIFICATIONS. THE DEVICE WAS RECEIVED AND THE POSITIONING GROOVE OF THE SCREW IS WIDENED. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-1 -D 1.4441. NO PRODUCT FAULT COULD BE FOUND. OUR INVESTIGATIONS HAVE SHOWN THAT THE POSITIONING GROOVE OF THE SCREW HAS BEEN WIDENED UP DUE TO INADEQUATE HANDLING. THE GROOVE IS EXPANDED AND DAMAGED AND THEREFORE THE PLATE DOES NOT PASS THE SLOTTED END OF THE DHS -DCS SCREW.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2012, IT WAS DISCOVERED THAT THE SLIDING MECHANISM WAS NOT WORKING. REPORTEDLY IT MAY HAVE BEEN THAT THE SCREW WAS TOO BIG FOR THE UNSPECIFIED PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272477 DHS/DCS-SCR Ø12.5 L105 SST KTT SYNTHES GMBH 7837296

    Patients

    Seq Age Sex Outcome Treatment
    1