BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARCANNULA-THREADED 5.5MMX75MM 5PK -ST

    MDR report key: 10077162 · Received May 20, 2020

    Report

    Report Number
    1221934-2020-01420
    Event Type
    Injury
    Date Received
    May 20, 2020
    Date of Event
    May 7, 2020
    Report Date
    May 8, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEA
    UDI-DI
    10886705003495
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT BY AFFILIATE VIA PERSONAL INTERACTION THE CLEARCANNULA-THREADED 5.5MMX75MM 5PK -ST. WHEN THE CANNULA (214108) WAS INSERTED, THE ASSISTANT SURGEON SAID THAT HE MIGHT HAVE NOTICED A CHIPPED ORANGE FRAGMENT OF THE CANNULA. ALTHOUGH THEY TRIED TO LOCATE THE FRAGMENT BY SEARCHING AROUND THE LESION WITH THE HELP OF A CAMERA, A LARGE AMOUNT OF SYNOVIUM HINDERED THE SEARCHING. THEY COMPLETED THE PROCEDURE AS SCHEDULED WITHOUT FINDING THE POSSIBLE FRAGMENT. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER, A PHOTO WAS PROVIDED. UPON VISUAL INSPECTION OF THE PHOTO, IN THE ORANGE CANNULA, WAS OBSERVED THAT DISTAL CYLINDER'S TIP WAS BROKEN. THE COMPLAINT REPORTED WAS CONFIRMED. THE PHOTO DOES NOT PROVIDE ENOUGH EVIDENCE TO DETERMINE ROOT CAUSE. HANDS ON ANALYSIS SHOULD PROVIDE THE EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE. AS RESPONSE OF THE SUPPLIER, THE POSSIBLE ROOT CAUSE FOR THE REPORTED FAILURE CAN BE CAUSED BY HARD CONTACT WITH SHARP WARE DURING THE CLINICAL PROCEDURE. THE SUPPLIER USE SPONGES WITH GLUE FOR THE PRODUCTION PROCESS TO AVOID CONTACTING THE HARD OBJECTS. PREVENTIVE ACTIONS, CORRECTIVE ACTIONS OR CAPA WERE NOT APPLICABLE FOR THE REPORTED FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [1903123] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [1903123] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AFFILIATE VIA PERSONAL INTERACTION THE CLEARCANNULA-THREADED 5.5MMX75MM 5PK -ST. WHEN THE CANNULA (214108) WAS INSERTED, THE ASSISTANT SURGEON SAID THAT HE MIGHT HAVE NOTICED A CHIPPED ORANGE FRAGMENT OF THE CANNULA. ALTHOUGH THEY TRIED TO LOCATE THE FRAGMENT BY SEARCHING AROUND THE LESION WITH THE HELP OF A CAMERA, A LARGE AMOUNT OF SYNOVIUM HINDERED THE SEARCHING. THEY COMPLETED THE PROCEDURE AS SCHEDULED WITHOUT FINDING THE POSSIBLE FRAGMENT. AS OF MAY 8, THE PATIENT WAS STABLE WITHOUT PAIN. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED. THE SALES REP TOOK AN ENLARGED IMAGE OF THE CANNULA¿S INNER CYLINDER WITH HIS SMARTPHONE AND NOTICED A TINY CHIPPED AREA ON THE CYLINDER¿S TIP. FURTHER MEDICAL INTERVENTION IS NOT PLANNED. NO SURGICAL DELAY REPORTED. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537672 CLEARCANNULA-THREADED 5.5MMX75MM 5PK -ST ARTHROSCOPIC DRAINAGE CANNULA GEA DEPUY MITEK LLC US 214108 1903123 10886705003495

    Patients

    Seq Age Sex Outcome Treatment
    1