BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSSEW III AC GUN

    MDR report key: 9193701 · Received October 15, 2019

    Report

    Report Number
    1221934-2019-59006
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    July 29, 2019
    Report Date
    September 19, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705025190
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. UPDATED DATA: 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.

    Additional Manufacturer Narrative · 0

    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. THE COMPLAINT DEVICE WAS RECEIVED AND VISUALLY INSPECTED.VISUAL OBSERVATIONS REVEALED THE UPPER JAW WAS LOOSE DUE TO JAW PIN MISSING.THIS COMPLAINT CAN BE CONFIRMED. CLAMPING EXCESSIVE TISSUE BETWEEN THE JAWS COMBINED WITH REPETITIVE TWISTING ACTION EXERTS EXCESS SIDE LOAD ON THE JAW PIN RESULTING IN THE JAW PIN SHEARING OFF FROM ITS SPACE. THIS FAILURE CAN BE ATTRIBUTED TO USER TECHNIQUE. FROM THE INFORMATION PROVIDED WE CANNOT DETERMINE THE DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [23433-140507] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT, 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 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [23433-140507] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). REPORTER IS COMPANY SALES REPRESENTATIVE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT PRIOR TO AN UNKNOWN CASE DURING SETTING IT WAS FOUND BY THE SCRUB TECH THAT THE JAW ON THE CUSTOMER'S EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER IS LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989234 EXPRESSSEW III AC GUN SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 10886705025190

    Patients

    Seq Age Sex Outcome Treatment
    1