BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III AC+ GUN

    MDR report key: 10831441 · Received November 12, 2020

    Report

    Report Number
    1221934-2020-03460
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LXH
    UDI-DI
    10886705027101
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING A SUPERIOR CAPSULE SHOULDER RECONSTRUCTION THE TIP OF THE EXPRESS III AUTO CAPTURE + SUTURE PASSER BROKE OFF. ANOTHER DEVICE USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEALED THAT THE EXPRESSSEW IS SLIGHTLY WORN AND USED, BUT IN EXPECTED CONDITION, ALSO THERE ARE SOME SPOTS OF LABEL ADHESIVE ON DEVICE¿S SURFACE. WHEN PERFORMING THE VISUAL INSPECTION, THE UPPER CAPTURE JAW WAS FOUND TO BE BROKEN. DUE TO THE CONDITION OF THE UPPER JAW, THE FUNCTIONAL TEST CANNOT BE PERFORMED. ACCORDING WITH THE VISUAL INSPECTION RESULT, THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE BROKEN JAW CAN BE ATTRIBUTED TO A LARGER AMOUNT OF TISSUE POSITIONED BETWEEN THE UPPER AND LOWER JAWS AND AN EXCESSIVE FORCE APPLIED TO THE DEVICE'S HANDLE, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [49141-181012-05] 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. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A SUPERIOR CAPSULE SHOULDER RECONSTRUCTION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE TIP OF THE EXPRESSEW III AUTOCAPTURE + SUTURE PASSER BROKE OFF. ANOTHER DEVICE USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297601 EXPRESSEW III AC+ GUN SUTURE/NEEDLE PASSER, REUSABLE LXH MEDOS INTERNATIONAL SARL 288233 10886705027101

    Patients

    Seq Age Sex Outcome Treatment
    1