BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3191880 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03641
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    December 9, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE EXAMINATION OF THE RETURNED SCREW DRIVER REVEALED THAT THE TOP WAS STRONGLY DEFORMED DUE TO EXCESS TORSIONAL LOAD AND BROKE OFF. IT IS ASSUMED THAT THE DEFORMATION OF THE TOP WAS CAUSED BY A MECHANICAL LOAD THAT WAS TOO HIGH. THE EXAMINATION OF MANUFACTURER DATA AND THE HARDNESS SPECIFICATIONS ALSO REVEALED NO DIVERGENCE FROM SPECIFICATIONS. NO PRODUCT ERRORS COULD BE DETERMINED.

    Description of Event or Problem · 1

    THE SCREWDRIVER SHAFT T25 TIP BROKE. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293440 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3410797

    Patients

    Seq Age Sex Outcome Treatment
    1