BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER Ø11 F/PFNA BLADE

    MDR report key: 3130949 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02404
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 15, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    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 NO COMPLAINT RELATED ISSUES WERE FOUND. THE ADDITIONAL EVALUATION REVEALED THAT THE TIP BROKEN OFF. THE MEASURABLE DIMENSION OF THE SUBMITTED DRILL WERE CHECKED AND FOUND TO BE IN COMPLIANCE. OUR INVESTIGATION SHOWED THAT THE COMPLAINED DRILL TIP HAS A HOMOGENOUS SURFACE. THEREFORE, WE CONCLUDE THAT THE DRILL TIP BROKE DUE TO EXCESSIVE MECHANICAL STRAIN. 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 OFF. DHS PLATE WOULD NOT SLIDE OVER SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231219 REAMER Ø11 F/PFNA BLADE HTO SYNTHES GMBH 410979

    Patients

    Seq Age Sex Outcome Treatment
    1