BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® LAG SCREW 12.7MM THREAD/100MM-STERILE

    MDR report key: 2944843 · Received February 5, 2013

    Report

    Report Number
    3003506883-2013-00743
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    June 23, 2010
    Report Date
    September 28, 2010
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE LOT NUMBER COULD NOT BE VERIFIED. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(4) COMPLAINT HANDLING UNIT REPORTED THE SCREW DID NOT FIT IN THE DYNAMIC HIP SYSTEM PLATE. 02.224.222S, LOT 246182. THE CUSTOMER CHECKED THE IMPLANTS BEFORE IMPLANTING THEM INTO THE PATIENT. WHEN THEY TRIED TO ASSEMBLE THE SCREW AND THE PLATE THEY FOUND THAT THE SCREW WAS TOO BIG FOR THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48186 DHS®/DCS® LAG SCREW 12.7MM THREAD/100MM-STERILE DHS®/DCS® LAG SCREW KTT SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1