BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECSCR F/DHS/DCS-WRENCH NO. 338.300

    MDR report key: 2935049 · Received January 30, 2013

    Report

    Report Number
    2520274-2013-00706
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    April 4, 2010
    Report Date
    April 12, 2010
    Manufacturer
    SYNTHES
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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

    EU COMPLAINT HANDLING UNIT REPORTED THE TIP OF THE CONNECTING SCREW FOR DYNAMIC HIP SYSTEM -DCS WRENCH, BROKE OFF WHILE INSERTING THE LAG SCREW. THE LAG SCREW WAS FULLY INSERTED WHEN THE TIP BROKE OFF AND WAS LEFT INSIDE THE LAG SCREW. THIS DID NOT INTERFERE WITH THE PLACEMENT OF THE LAG SCREW OF THE DHS PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40983 CONNECSCR F/DHS/DCS-WRENCH NO. 338.300 CONNECSCR F/DHS/DCS HXC SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1