BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3193660 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03253
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    August 18, 2011
    Report Date
    September 17, 2011
    Manufacturer
    SYNTHES, USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. (B)(6). 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THE T25 SCREWDRIVER SHAFT, THE TIP OF THE SHAFT, BROKE WHILE THE SURGEON WAS PERFORMING FINAL TIGHTENING. THE BROKEN PIECE WAS RETRIEVED FROM THE SCREW HEAD. THE SURGEON THEN TRIED TO USE THE T25 SCREWDRIVER T-HANDLE STARDRIVE, AND WAS UNABLE TO USE IT BECAUSE THE HANDLE WAS UNSTABLE AND UNABLE TO BE USED. THIS IS 1 OF 1 REPORT FOR EVENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293218 SCRDRIVERSHAFT T25 F/URS HTW SYNTHES, USA

    Patients

    Seq Age Sex Outcome Treatment
    1