BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVERSHAFT T25 F/URS

    MDR report key: 3161324 · Received June 11, 2013

    Report

    Report Number
    8030965-2013-03046
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 ADDITIONAL EVALUATION REVEALED THAT THE TIP OF SCREWDRIVERS BROKE OFF. THE FRACTURE SURFACE IS HOMOGENEOUS, WHICH INDICATES MATERIAL CONFORMITY AS WELL. BASED ON THESE FINDINGS, WE CONCLUDE THAT THE CAUSE OF FAILURE IS RELATED TO A MECHANICAL OVERLOADING DURING USE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF THE SCREWDRIVERS BROKE OFF. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263316 SCRDRIVERSHAFT T25 F/URS HXX SYNTHES GMBH 3571632

    Patients

    Seq Age Sex Outcome Treatment
    1