BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPERT END CAP SOLID EXTENS. 10 F/HN TAN

    MDR report key: 3625656 · Received February 12, 2014

    Report

    Report Number
    1719045-2014-00102
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K033071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING THE OPERATION OF PROXIMAL HUMERUS, THE SURGEON PICKED A 10MM EXTENSION END CAP, BECAUSE THE PROXIMAL PART OF THE NAIL WAS FOUND TO BE PLANTED DEEP INTO THE BONE HEAD. THE SURGEON TRIED TO INSERT THE END CAP WITH A DRIVER, BUT IT CONTINUED SPINNING AROUND AND COULDN'T BE INSERTED. THE SURGEON TRIED A 5MM EXTENSION END CAP INSTEAD, IT WAS INSERTED WITHOUT PROBLEM. THE OPERATION WAS COMPLETED WITH 20-MINUTE DELAY. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93890 EXPERT END CAP SOLID EXTENS. 10 F/HN TAN JDS SYNTHES MONUMENT 8002690

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown