BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-IMPACT F/ONE-STEP INSERT-TECHN F

    MDR report key: 2960292 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-00460
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GFA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS CONDUCTED AT SYNTHES (B)(4). THE BROKEN ARTICLE, IN ORIGINAL PACKAGING WAS RECEIVED. THE INVESTIGATION HAS SHOWN THAT THE BLACK PLASTIC PART IS BROKEN OFF AT THE CONNECTION TO THE BOLT. THE EXACT CAUSE OF FAILURE CANNOT BE CLEARLY DETERMINED. SINCE THESE INSTRUMENTS ARE SUBJECTED TO A FINAL INSPECTION, IT MAY BE ASSUMED THAT THE FAILURE OCCURRED DURING THE TRANSPORT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: HOSPITAL RECEIVED THE DHS/DCS IMPACTOR BROKEN IN THE ORIGINAL PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64176 DHS/DCS-IMPACT F/ONE-STEP INSERT-TECHN F DHS/DCS-IMPACTOR GFA SYNTHES GMBH 3668123

    Patients

    Seq Age Sex Outcome Treatment
    1