BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED

    MDR report key: 6749323 · Received July 27, 2017

    Report

    Report Number
    1221934-2017-10388
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    June 28, 2017
    Report Date
    June 28, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    GEA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. A DHR REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE, THERE IS NO EVIDENCE OF MANUFACTURING ANOMALIES ON THE PAPERWORK REVIEWED. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED ONE SIMILAR COMPLAINT FOR THIS LOTS OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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. UDI: (B)(4).

    Description of Event or Problem · 1

    AFFILIATE REPORTED VIA EMAIL A CANNULA FOR SHOULDER ARTHROSCOPY PORTAL IS USED, AN INNER MEMBRANE OF THE CANNULA (COD. 214120), WHICH IS TO CONTAIN THE WATER IN THE JOINT, CAME OFF. AS IT WAS THE FIRST TIME THAT HAPPENED, WE ASSUMED THAT IT WAS SOMETHING PUNCTUAL OR CUSTOMER ERROR, WHICH IS NEW WITH OUR PRODUCTS. THERE WAS NO DAMAGE TO THE PATIENT. THE SURGEON KEPT USING THE SAME CANNULA. HE COULD REMOVE THE INNER MEMBRANE, JUST LOST A LITTLE BIT MORE WATER, BUT COULD REMOVE IT AND COMPLETE THE PROCEDURE WITHOUT PROBLEMS. THERE WAS NO DELAY IN THE PROCEDURE DUE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528007 CLEAR CANNULA SYSTEM 8.5 X 75 MM ¿ THREADED MITEK ARTHROSCOPIC INSTRUMENTS GEA DEPUY MITEK 1510191

    Patients

    Seq Age Sex Outcome Treatment
    1