BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-SCR Ø12.5 L100 SST

    MDR report key: 2971268 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-00562
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. OUR INVESTIGATION SHOWS THAT THE POSITIONING GROOVE OF THE SCREW HAS BEEN WIDENED UP DUE TO INADEQUATE HANDLING. AS THE GROOVE IS EXPANDED AND DAMAGED THE PLATE DOES NOT PASS THE SLOTTED END OF THE DHS, DCS 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 MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND, THE INSTRUMENT CONFORMS TO OUR SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PROCEDURE THE DHS/DCS SCREW DID NOT FIT INTO THE DHS PLATE. ANOTHER SCREW WAS SELECTED AND IT WORKED OUT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77407 DHS/DCS-SCR Ø12.5 L100 SST DHS/DCS-SCREW KTT SYNTHES GMBH 8145571

    Patients

    Seq Age Sex Outcome Treatment
    1