BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING SAW ATTCHMT/LARGE W/KEY FOR SMALL BATTERY DRIVE

    MDR report key: 2993272 · Received March 7, 2013

    Report

    Report Number
    8030965-2013-00791
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    March 1, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR REWORK AND WAS SUBSEQUENTLY UPGRADED AND REPAIRED AND THEN RETURNED TO THE FIELD. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT. IF ANY OTHER INFORMATION IS RECEIVED THIS WILL BE REPORTED VIA A SUPPLEMENT.

    Description of Event or Problem · 1

    REWORK PER RECALL # 139.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97873 OSCILLATING SAW ATTCHMT/LARGE W/KEY FOR SMALL BATTERY DRIVE SAW GFA SYNTHES GMBH XXX1153

    Patients

    Seq Age Sex Outcome Treatment
    1