BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3141406 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02619
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    March 31, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 MANUFACTURING DATA AND HARDNESS SPECIFICATIONS DID NOT REVEAL ANY DEVIATIONS FROM SPECIFICATION. NO PRODUCT DEFECT WAS ESTABLISHED. THE VISUAL INSPECTION OF THE SCREWDRIVER HAS SHOWN THAT THE ENTIRE TIP BROKE OFF DUE TO EXCESSIVE TORSIONAL LOAD. IT IS POSSIBLE THE DAMAGE WAS CAUSED BY THE USE OF THE FIXED T-HANDLE AS IT ALLOWS FOR THE APPLICATION OF GREATER TORSIONAL TORQUE. THE BREAK SURFACE IS HOMOGENEOUS, WHICH IS INDICATIVE OF FLAWLESS MATERIAL QUALITY. THE INVESTIGATION DETERMINED THIS COMPLAINT TO BE INVALID. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    TIP BROKEN DURING TIGHTENING OF THE SCREW. BROKEN PART WAS RETRIEVED AND RETURNED. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243797 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3087297

    Patients

    Seq Age Sex Outcome Treatment
    1