BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER F/CLICKX LOCKCAP SELF-HOLD W/T

    MDR report key: 2841271 · Received November 21, 2012

    Report

    Report Number
    8030965-2012-01317
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE, THE SCREWDRIVER BROKE WHILE TIGHTENING THE LOCKING CAP TO THE ROD AND 3D-HEAD. THE BROKEN FRAGMENT WAS RETRIEVED. THE SURGEON WAS ABLE TO USE ANOTHER DEVICE. REPORTEDLY THE PATIENT WAS NOT IMPACTED BY THIS EVENT AND THIS EVENT DID NOT REQUIRE ADDITIONAL MEDICAL TREATMENT. THE PROCEDURE WAS DELAYED BY AN UNKNOWN AMOUNT OF TIME. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCRDRIVER F/CLICKX LOCKCAP SELF-HOLD W/T SCREWDRIVER HXX SYNTHES GMBH 3802420

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCKING CAP