BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III W/O HOOK

    MDR report key: 10323667 · Received July 24, 2020

    Report

    Report Number
    1221934-2020-01917
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 10, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705020218
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: ADDITIONAL INFORMATION: B5: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE EVENT OCCURRED PREOPERATIVELY TO ROTATOR CUFF REPAIR SURGERY. THE SURGERY WAS COMPLETED WITH ANOTHER LIKE DEVICE WITHOUT DELAY AND PATIENT CONSEQUENCE. H6: METHOD CODES: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [11561-120426] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    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 THE DISTAL TIP OF TWO EXPRESSEW III SUTURE PASSER W/O HOOK WAS FLAPPING AROUND.THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [11561-120426] 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE DISTAL TIP OF TWO EXPRESSEW III SUTUER PASSER W/O HOOK WAS FLAPPING AROUND. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THE CALL. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785317 EXPRESSEW III W/O HOOK SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 214140 10886705020218

    Patients

    Seq Age Sex Outcome Treatment
    1