BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III SUTURE PASSER W/ HOOK

    MDR report key: 16126670 · Received January 9, 2023

    Report

    Report Number
    1221934-2023-00171
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    November 11, 2022
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705003655
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. UDI: (B)(4). INVESTIGATION SUMMARY : THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED. UPON VISUAL INSPECTION REVEALED MARKS OF USED IN THE DEVICE. THE NEEDLE WAS FOUND STUCK INTO THE SHAFT OF THE DEVICE AND THE DISTAL TIP WAS DAMAGE; THE WHITE FLAG WAS MISSING. FINALLY, THE JAWS WERE FOUND IN GOOD CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER: 62108-220127-09, AND NO NON-CONFORMANCE WERE IDENTIFIED. ACCORDING WITH THE VISUAL INSPECTION RESULT, THIS COMPLAINT CAN BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR DEPLOYMENT ISSUE CAN BE ATTRIBUTED AN IMPROPER MAINTENANCE WOULD LEAD TO BIO-DEBRIS BUILD UP INSIDE THE EXPRESSEW SHAFT CAUSING WEAR OF INTERNAL COMPONENTS LEADING TO ROUGH DEPLOYMENT ISSUES. AS PER IFU, IT IS IMPORTANT TO INSPECT THE DEVICE PRIOR TO USE TO ENSURE PROPER MECHANICAL FUNCTION AND DO NOT USE IF PRODUCT IS DAMAGED. ALSO, IT IS NECESSARY TO FOLLOW THE INSTRUCTIONS TO CLEANING AND STERILIZATION PROCESS AND BETWEEN USES, LUBRICATE MOVING PARTS WITH THE WATER-SOLUBEL LUBRICANT. APPLYING TOO MUCH FORCE WHEN GRASPING TISSUE WILL IMPEDE PASSAGE OF THE NEEDLE AND SUTURE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, IN DEPUY SYNTHES MITEK, ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT WHILE USING A EXPRESSEW III SUTURE PASSER W/ HOOK DEVICE, THE PLASTIC FLAG ON THE EXPRESSEW III NEEDLE DEVICE FELL OFF CAUSING THE NEEDLE TO JAM IN THE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT A NEEDLE WAS FOUND STUCK INTO THE SHAFT OF THE DEVICE. 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
    184257 EXPRESSEW III SUTURE PASSER W/ HOOK SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 214124 62108-220127-09 10886705003655

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown