BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIX-SLEEVE F/03.010.078

    MDR report key: 3133795 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02457
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FIXATION SLEEVES SHOWS SEVERAL SIGNS OF WEAR AND TEAR DUE TO FREQUENT USE. THE ANGLES ARE ROUNDED AS A RESULT OF WEAR. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. SINCE THIS COMPLAINT, THE MATERIAL OF THIS INSTRUMENT HAS SINCE BEEN UPDATED TO IMPROVE RESISTANCE IN THIS AREA. AS A RESULT OF THE RISK ANALYSIS AND AS A RESULT OF THE ALREADY IMPLEMENTED MEASURES, NO FURTHER ACTIONS WERE TAKEN.

    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). PLACEHOLDER.

    Description of Event or Problem · 1

    FIXATION BETWEEN REAMER WAS LOOSE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235598 FIX-SLEEVE F/03.010.078 HTC SYNTHES GMBH 3155526

    Patients

    Seq Age Sex Outcome Treatment
    1