BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKSCR Ø5 L56 F/NAILS TAN LIGHT GREEN

    MDR report key: 3101716 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02150
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SCREWS THAT CANNOT BE REMOVED FROM THE SCREWDRIVER DURING A PROCEDURE ON (B)(6) 2013. ONE SCREW OF FOUR WAS NOT ABLE TO BE REVERSED OUT WITH THE SCREWDRIVER. THIS WAS USED WITH THE FEMUR NAIL IMPLANT. THE LOCKING SCREWS 5.0MM FOR SSFN THAT HAVE BEEN TRIED IN THE DRYLAB IN SAWBONES. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202744 LOCKSCR Ø5 L56 F/NAILS TAN LIGHT GREEN HWC SYNTHES GMBH 3817276

    Patients

    Seq Age Sex Outcome Treatment
    1