BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3181244 · Received June 21, 2013

    Report

    Report Number
    8030965-2013-03778
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 30, 2012
    Report Date
    May 3, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SCREWDRIVERS WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOTS IN QUESTION. IT IS POSSIBLE THAT THE SCREWS WERE TIGHTENED UP WITH FAR TOO MUCH FORCE, USING THE TORQUE-LIMITING HANDLE, AND CAUSED THESE BREAKAGES OF THE TIPS. THE FRACTURED SURFACES ARE HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON CONFORMANCES. NO PRODUCT OR MATERIAL RELATED CONDITION WAS FOUND, THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID. (B)(6).

    Description of Event or Problem · 1

    THE INSTRUMENTS WERE BEING USED TO APPLY FINAL TIGHTENING TO THE LOCKING CAPS ON THE CONSTRUCT WHEN THE TIPS BROKE. THIS IS 2 OF 2 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281979 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3755881

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR