BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSSEW III AC GUN

    MDR report key: 14279310 · Received May 4, 2022

    Report

    Report Number
    1221934-2022-01265
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 13, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705025190
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT WAS DISCARDED BY THE CUSTOMER, 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 (30994-150223-09), AND NO NON-CONFORMANCE WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY SALES REP THAT DURING A SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE EXPRESSEW III AUTOCAPTURE FLEXIBLE SUTURE PASSER DEVICE FAILED TO WORK. ACCORDING TO THE REPORT, THE PRONGS ON THE DEVICE WERE BENT THAT IT COULD NOT BE ATTACHED TO DISPOSABLE AUTOCAPTURE PLATE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822883 EXPRESSSEW III AC GUN SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 214157 30994-150223-09 10886705025190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown