BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3003481 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10224
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    June 15, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    LXH
    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

    ADDITIONAL NARRATIVE: 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 FILLING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED NICKS, SCRATCHES AND WEAR ON THE GOLD HANDLE AND ON THE SHAFT AND ALIGNMENT INDICATOR. THE PRODUCT INVESTIGATION REVEALED THIS COMPLAINT TO BE INDETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ASSEMBLING THE STERILE TRAY, THE HELICAL BLADE INSERTER WAS BROKEN ON THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85847 HELICAL BLADE INSERTER LXH SYNTHES (USA) BRANDYWINE 4905130

    Patients

    Seq Age Sex Outcome Treatment
    1