BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/105MM-STERILE

    MDR report key: 3175058 · Received June 18, 2013

    Report

    Report Number
    8030965-2013-03492
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Report Date
    July 2, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 POSITIONING GROOVE OF THE SCREWS 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-SCREW. IN ORDER TO ENSURE A CORRECT LOAD TRANSFER AND TO PREVENT SUCH OCCURRENCE, IT IS VERY IMPORTANT TO HAVE AN APPROPRIATE CONNECTION BETWEEN THE DHS-SCREW AND THE CONNECTING SCREW 338.310, WHICH IS GUIDED THROUGH THE WRENCH 338.300. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND; THE IMPLANTS CONFORM TO OUR SPECIFICATIONS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DYNAMIC HIP SYSTEM (DHS) SCREWS DID NOT FIT INTO THE DHS PLATE DURING A PROCEDURE ON AN UNKNOWN DATE. THE SCREWS WERE TRIED WITH A DIFFERENT DHS PLATE AND THE RESULTS WERE THE SAME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276813 DHS®/DCS® LAG SCREW 12.7MM THREAD/105MM-STERILE KTT SYNTHES GMBH 2696184

    Patients

    Seq Age Sex Outcome Treatment
    1