BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III NEEDLE

    MDR report key: 15729943 · Received November 4, 2022

    Report

    Report Number
    1221934-2022-03405
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    August 1, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705020225
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. ADDITIONAL NARRATIVE: UDI: (B)(4). INVESTIGATION SUMMARY THE DEVICE WAS RECEIVED AND EVALUATED. UPON VISUAL INSPECTION, THE DEVICE COMES IN USED CONDITION AS EXPECTED ON REUSABLE DEVICES. THE DEVICE DOES NOT SHOW ANY STRUCTURAL ANOMALIES. THE UPPER JAW IS NOT BENT OR BROKEN. THE PASSER WAS FOUND BROKEN AND STUCK INSIDE THE DEVICE AND IT WAS NOT POSSIBLE TO REMOVE IT FROM THE DEVICE. SINCE THE NEEDLE IS STUCK INSIDE THE DEVICE, THE FUNCTIONAL TEST CANNOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 57471-200324-07 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ACCORDING WITH THE VISUAL INSPECTION RESULT, THIS COMPLAINT CAN BE CONFIRMED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO PROCEDURAL VARIABLES, SUCH HANDLING OF THE DEVICE OR PRODUCT INTERACTION DURING PROCEDURE; REPEATEDLY PASSING THE NEEDLE THROUGH EXCESSIVE TISSUE; ANY USE BEYOND THIS WOULD CAUSE THE NEEDLE TO FATIGUE AND THEN BREAK. ALSO, IT COULD BE RELATED WHEN DEPLOYING THE NEEDLE WITH THE JAWS OPEN WHICH CAN LEAD TO A BROKEN NEEDLE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. 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 A HEALTHCARE PROFESSIONAL IN ITALY THAT DURING AN UNKNOWN SURGERY ON(B)(6)2022 , IT WAS OBSERVED THAT THE EXPRESSEW III NEEDLE DEVICE REMAINED STUCK INTO THE EXPRESSEW III NEEDLE HOLDER WHILE IN USE TOGETHER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE PASSER WAS BROKEN, STUCK INSIDE THE DEVICE AND THEREFORE, WAS NOT POSSIBLE TO BE REMOVED FROM THE DEVICE. 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
    2816304 EXPRESSEW III NEEDLE SUTURE/NEEDLE PASSER, SINGLE-USE LXH DEPUY MITEK LLC US 214141 57471-200324-07 10886705020225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown