BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-SCR Ø12.5 L105 SST

    MDR report key: 3131782 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02418
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    January 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 POSITION GROOVE OF THE SCREW HAS BEEN WIDENED, DUE TO POSSIBLE INADEQUATE HANDLING. THE GROOVE IS EXPANDED AND DAMAGED, 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, WHICH IS GUIDED THROUGH THE WRENCH. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND; THE IMPLANTS CONFORM TO SPECIFICATIONS, PRODUCT FAULT WAS NOT FOUND.

    Description of Event or Problem · 1

    THE PLATE DID NOT FIT OVER THE SCREW. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235525 DHS/DCS-SCR Ø12.5 L105 SST KTT SYNTHES GMBH 2640688

    Patients

    Seq Age Sex Outcome Treatment
    1