BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 POLYAXIAL SCREW 6.0X40MM

    MDR report key: 3187408 · Received June 21, 2013

    Report

    Report Number
    3005673311-2013-00082
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 18, 2013
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWP
    PMA / PMN Number
    K032219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FOR ANALYSIS WE RECEIVED THE FOLLOWING COMPONENTS IN USE WITH THE SCREW AT THE TIME OF THE MALFUNCTION REPORT: S4 SET SCREW NEW VERSION: SW790T, LOT 51896814; SW790T, LOT 51800622; AND SW790T, LOT 51895971; SW773T, LOT 5183160: ONE OF THE TABS OF THE POLYAXIAL SCREW HAS BROKEN OFF AND IS NOT PRESENT; THE THREAD CAN THEREFORE NOT BE ANALYZED. THERE IS NO MARKING INSIDE THE POLYAXIAL SCREW FROM THE ROD, SW790T LOT 51896814 X 2: ONE SET-SCREW EXHIBITS A SHEARED THREAD AND EXTREME WEAR MARKING ON THE UNDERSIDE. ONE SET-SCREW EXHIBITS NO MARKING AND APPEARS UNUSED, SW790T LOT 51800622: THE SET-SCREW EXHIBITS MARKING ON THE UNDERSIDE FROM SCREWING DOWN ON THE ROD. THE MARKING IS NOT COMPLETELY CIRCULAR AND THEREFORE HAS NOT PUSHED THE ROD THE WHOLE WAY DOWN. THE THREAD AND THE TOP SURFACE OF THE SCREW EXHIBIT SLIGHT MARKING. THE THREAD IS INTACT, SW790T LOT 51895971: THE THREAD OF THE SET-SCREW IS STRIPPED. EXTREME CIRCULAR WEAR MARKING ON THE UNDERSIDE INDICATES THAT THE SET-SCREW WAS USED TO PUSH THE ROD DOWN INTO THE POLYAXIAL SCREW. THE APPEARANCE OF THE COMPONENTS SUGGESTS THAT THE ROD WAS NOT FULLY INSERTED INTO THE BODY OF THE POLYAXIAL SCREW. FURTHERMORE THAT THE ROD WAS PRESSED DOWN USING THE SET-SCREWS (HENCE DISTINCTIVE WEAR MARKING). ALL COMPONENT LOT NUMBERS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO INDICATIONS FOR A MATERIAL OR MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). ONE SIDE OF THE SCREW HEADS WAS BROKEN WHEN THE ROD WAS TO BE INSERTED. ROD WASN'T ABLE TO BE INSERTED PROPERLY AND SO SURGEON CHANGED A NEW SCREW FOR REPLACEMENT. TIME DELAY ESTIMATED GREATER THAN 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283653 S4 POLYAXIAL SCREW 6.0X40MM KWP AESCULAP AG & CO. KG SW773T 51831604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other