BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR

    MDR report key: 3003338 · Received February 28, 2013

    Report

    Report Number
    8030965-2013-10311
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 02/2012. 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 SAMPLE WAS RECEIVED IN GOOD CONDITION. THE INSTRUMENT CORRESPONDS TO DRAWINGS AND PROCESSES ACCORDING TO MANUFACTURING REQUIREMENTS. DISCOLORATION WAS NOT FOUND ON THE INSTRUMENT. MEASURABLE DIMENSIONS WERE FOUND WITHIN TOLERANCE. A REVIEW OD THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS COMPLAINT IS INVALID FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT RESIN HANDLES ARE LEACHING BROWN FROM THE HANDLE. THIS IS 9 OF 10 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86527 RETRACTOR GAD SYNTHES GMBH A7IA20

    Patients

    Seq Age Sex Outcome Treatment
    1