BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNISPAN MENISCAL REPAIR 12 DEGREE NEEDLE

    MDR report key: 1791896 · Received August 4, 2010

    Report

    Report Number
    1221934-2010-00262
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THE MEDWATCH IS TO DOCUMENT THIS EVENT BECAUSE A PIECE OF THE SILICONE TUBING FELL OFF INTO THE JOINT SPACE, AND HAD TO BE RETRIEVED. THE NEW PRODUCT DEVELOPMENT (NPD) QUALITY ENGINEERS HAVE BEEN MADE AWARE OF THIS ISSUE. A REVIEW OF THE BATCH RECORD INDICATES THE LOT WAS MANUFACTURED WITHOUT INCIDENT. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE SILICONE TUBE DETACHED FROM THE NEEDLE AND WAS LEFT IN THE JOINT SPACE UPON REMOVAL OF THE NEEDLE AND APPLIER AFTER THE PROCEDURE WAS COMPLETE. IT WENT UNNOTICED UNTIL THE SURGEON WENT IN FOR A FINAL LOOK, AND HE REMOVED THE SILICONE TUBE WITH A GRASPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNISPAN MENISCAL REPAIR 12 DEGREE NEEDLE OMNISPAN NEEDLE 12 DEGREE HRX DEPUY MITEK 228141 3400971

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK