BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM REAMER HEAD Ø11.5

    MDR report key: 3171609 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02780
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    February 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    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. THE VISIBLE INSPECTION OF THE HEAD DRILL SHOWS THAT TRACES OF RUST ARE VISIBLE, THESE TRACES CAN BE REMOVED BY MECHANICAL MEANS. THE TRACES OF RUST ARE CAUSED BY AN ACCUMULATION OF CONTACT CORROSION. THE MATERIAL WILL ONLY BE RESISTANT TO RUST IF IT IS DRY AND STORED IN A WAY SO IT WILL NOT COME INTO CONTACT WITH METAL OBJECTS. ALL METALLIC CONTACTS IN MOIST OR WET CONDITIONS WILL RESULT IN ELECTROLYTIC REACTIONS WITH CONTACT CORROSION. THIS IS A NORMAL SIGN OF WEAR AND TEAR. THE LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    RUST ON THE SURFACE OF INSTRUMENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272501 SYNREAM REAMER HEAD Ø11.5 HTO SYNTHES GMBH 17134

    Patients

    Seq Age Sex Outcome Treatment
    1