BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AO/ASIF REAMING ATTACHMENT

    MDR report key: 2945321 · Received February 1, 2013

    Report

    Report Number
    8030965-2013-10021
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 11, 2011
    Report Date
    January 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED (B)(4) 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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. HOWEVER, THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DURING A TIBIAL INSERTION, THE REMAINING ATTACHMENT MALFUNCTIONED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44086 AO/ASIF REAMING ATTACHMENT GEY SYNTHES GMBH 1326393

    Patients

    Seq Age Sex Outcome Treatment
    1