BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1392 5.9MM STRYKER SHEATH 2 WAY -NS

    MDR report key: 8290838 · Received January 30, 2019

    Report

    Report Number
    1221934-2018-53724
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    May 1, 2017
    Report Date
    May 8, 2017
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HNX
    UDI-DI
    10886705016099
    PMA / PMN Number
    K951702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED. VISUALLY INSPECTION REVEALS THAT THE METAL COUPLER PART OF THE SHEATH WAS BROKEN OFF THE DEVICE. THE DEVICE WAS REVIEWED WITH THE DESIGN AND QUALITY ENGINEERS FOR THIS PRODUCT. THEY SAID THAT THE LASER WELD THAT HOLD THIS PART TO THE SHEATH IS BROKEN OFF. THE WELD MARKS ARE VISIBLE ON THE PARTS. THEY SUSPECT THAT THE DEVICE WAS DROPPED ON A HARD SURFACE WHICH CAUSED THIS WELD TO BREAK. THIS COMPLAINT CAN BE CONFIRMED. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY TYPE FOR THE SERIAL NUMBER OF THIS DEVICE THAT WAS 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). THE SERIAL NUMBER IS NOT AVAILABLE.

    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. UDI: (B)(4). THIS REPORT IS BEING FILED FROM THE ETQ COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE 5.9 NN STRYKER SHEATH COUPLER WAS BROKEN CAUSING IT NOW TO HOLD THE LENS. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81223 1392 5.9MM STRYKER SHEATH 2 WAY -NS RIGID ENDOSCOPE SHEATH HNX DEPUY MITEK LLC US 10886705016099

    Patients

    Seq Age Sex Outcome Treatment
    1