BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III AC+ GUN

    MDR report key: 11596891 · Received March 31, 2021

    Report

    Report Number
    1221934-2021-01043
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 16, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LXH
    UDI-DI
    10886705027101
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS NOT RETURNED AFTER MULTIPLE ATTEMPTS FOR DEVICE RETURN, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER (46720-180226-02), AND NO NON-CONFORMANCE WAS IDENTIFIED.SHOULD THE DEVICE EVER BE RECEIVED BACK IN THE FUTURE, THIS COMPLAINT FILE WILL BE REOPENED AT THAT TIME AND AN EVALUATION WILL BE PERFORMED AND DOCUMENTED. 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.

    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. ADDITIONAL NARRATIVE: 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 ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TOP JAW ON THE SUTURE PASSER DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496055 EXPRESSEW III AC+ GUN SUTURE/NEEDLE PASSER, REUSABLE LXH MEDOS INTERNATIONAL SARL 288233 10886705027101

    Patients

    Seq Age Sex Outcome Treatment
    1