BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø4.5 L36 SST

    MDR report key: 3130661 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02346
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 27, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K974537
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION COORDINATED BY SYNTHES (B)(4) REPORTS THE FOLLOWING: THE CORTEX SCREW WAS AS FAR AS POSSIBLE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORDS (DHR) WAS REVIEWED; NO ABNORMAL FINDINGS WERE IDENTIFIED. IT CAN BE CONCLUDED THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. FURTHER, AND ALTHOUGH THE EXACT CAUSE FOR THE DEVICE MALFUNCTION COULD NOT BE DETERMINED, THE FINDINGS FROM THE INVESTIGATION REASONABLY SUGGESTS THAT AN EXCESSIVE CONTACT BETWEEN THE SCREW AND THE PLATE CAUSED THE OUTER PART OF ITS THREAD FLANK TO SHEAR OFF. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2013, THE STAFF NOTICED A THREAD OF METAL COMING AWAY FROM THE SCREW. THIS OCCURRED AS THE SURGEON WAS INSERTING THE SCREW. THE SURGEON DECIDED TO REMOVE IT. AS HE DID THIS, A LARGER THREAD CAME AWAY. IT WAS STATED THAT THIS DID NOT CAUSE A SIGNIFICANTLY LONG DELAY IN THE SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231315 CORTSCR Ø4.5 L36 SST KTT SYNTHES GMBH 8182642

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR