BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III AC+ GUN

    MDR report key: 13170778 · Received January 5, 2022

    Report

    Report Number
    1221934-2022-00012
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    September 27, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    LXH
    UDI-DI
    10886705027101
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING ARTHROSCOPIC CUFF SURGERY. THE EXPRESSEW DID NOT OPEN/CLOSE AS IT SHOULD. IT STAYS OPEN. THE SURGEON HAS USED EXPRESSEW FOR MANY YEARS AND HAD NO ISSUES BEFORE. THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED PROVIDED BY CUSTOMER. THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL OBSERVATIONS REVEALED THAT THE DEVICE HAD MARKS OF WEAR BAND THE LASER MARKS WERE SLIGHTLY FADED. TO TEST ITS FUNCTIONALITY, IT WAS TESTED ON A SAMPLE RUBBER STRIP; AS A RESULT, THE UPPER JAW WAS SLIGHTLY LOOSE WHEN THE JAWS ARE CLOSED; THEREFORE, IT SHOWED THAT THE JAWS DID NOT CLOSE NORMALLY CONTRIBUTING TO THE HOLDING ISSUE. THE SHEAR PIN IS MISSING, AND THE ASSEMBLY OF THE JAW MECHANISM WAS BROKEN. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER:41483-170131-09, AND NO NON-CONFORMANCES WERE IDENTIFIED. BASED ON THE RESULTS, THIS COMPLAINT CAN BE CONFIRMED. UPON FURTHER INVESTIGATION IT WAS FOUND THAT THE SHEAR PIN INSIDE THE HANDLE OF THE DEVICE HAD FAILED, ELIMINATING THE LINKAGE BETWEEN THE JAW LEVER AND THE ACTUATOR, PREVENTING FUNCTIONALITY OF THE JAW. THIS SHEAR PIN IS A DESIGN FEATURE TO ENSURE THAT THE TISSUE IS CLAMPED AND PREVENT LOOSE BODIES FROM LEAVING THE DEVICE THE POSSIBLE ROOT CAUSE FOR THE ISSUE EXPERIENCED CAN BE ATTRIBUTED WHEN CLAMPING EXCESSIVE TISSUE BETWEEN THE JAWS COMBINED WITH REPETITIVE TWISTING ACTION EXERTS EXCESS LOAD ON THE JAWS CAUSING IT TO EVENTUALLY DAMAGE THE JAW; ALSO, IT IS POSSIBLE THAT THE FAILURE OCCURRED DUE TO EXCESSIVE MECHANICAL FORCE WHILE HANDLING THE DEVICE. SINCE THIS IS A REUSABLE DEVICE, THIS FAILURE HAS POSSIBLY OCCURRED AFTER USING IT IN THIS MANNER FOR MANY PROCEDURES. AS PER IFU, IT IS IMPORTANT TO INSPECT THE DEVICE PRIOR TO USE TO ENSURE PROPER MECHANICAL FUNCTION. VISUALLY INSPECT THE INSTRUMENT AND CHECK FOR DAMAGE AND WEAR. ALSO, JAWS AND TEETH SHOULD ALIGN PROPERLY. 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 THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE EXPRESSEW III AC+ GUN DEVICE DID NOT OPEN/CLOSE AS IT SHOULD; AND THAT IT STAYED OPEN. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE UPPER JAW WAS SLIGHTLY LOOSE WHEN THE JAWS WERE CLOSED AND THE ASSEMBLY OF THE JAW MECHANISM WAS BROKEN ON THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56501 EXPRESSEW III AC+ GUN SUTURE/NEEDLE PASSER, REUSABLE LXH MEDOS INTERNATIONAL SARL 288233 41483-170131-09 10886705027101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown