BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSEW III W/HOOK

    MDR report key: 11614633 · Received April 5, 2021

    Report

    Report Number
    1221934-2021-01081
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    February 16, 2021
    Report Date
    March 31, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705003655
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: ACCORDING TO THE INFORMATION RECEIVED, THE JAW OF THE EXPRESSEW III SUTURE PASSER W/ HOOK WAS DAMAGE. SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS RETURNED TO MITEK FOR EVALUATION. MITEK THEN CONDUCTED VISUAL INSPECTION OF DEVICE RECEIVED. VISUAL ANALYSIS OF THE RETURNED DEVICE, DETERMINED THAT UPPER JAW WAS BENT. IN ADDITION, THE DEVICE IS SLIGHTLY WORN, USED BUT IN EXPECTED CONDITION. TO TEST ITS FUNCTIONALITY, A NEEDLE WAS LOADED INTO THE DEVICE AND WAS TESTED ON A SAMPLE RUBBER STRIP. THE RESULTS WERE SATISFACTORILY. THE DEVICE WAS TESTED SEVERAL TIMES TO ENSURE THE PROPER FUNCTIONING. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER:47210-180626-07, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. BASED ON THE INFORMATION CURRENTLY AVAILABLE. PRODUCT EVALUATION OF THE RETURNED DEVICE INDICATES THAT THE JAW COULD HAVE BEING BENT DUE TO EXCESSIVE FORCE APPLIED DURING THE PROCEDURE ON BONE OR SIMILAR HARD TISSUE. AS PER IFU-110114, VISUALLY INSPECT THE INSTRUMENT AND CHECK FOR DAMAGE AND WEAR. JAWS AND TEETH SHOULD ALIGN PROPERLY. IN THIS CASE, IT CAN BE CONCLUDED THAT ROOT CAUSE OF THE FAILURE REPORTED IS DUE TO HANDLING OF THE DEVICE, ALSO CAN BE ASSOCIATED TO FAIR WEAR AND TEAR OF THE DEVICE DUE TO REPEATED USE AND STERILIZATION CYCLES., HOWEVER; IT CANNOT BE CONCLUSIVELY AFFIRMED. AS PART OF MITEK¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS 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 · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2021, IT WAS OBSERVED THAT THE SUTURE PASSER DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE UPPER JAW WAS BENT ON THE DEVICE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511716 EXPRESSEW III W/HOOK SUTURE/NEEDLE PASSER, REUSABLE LXH DEPUY MITEK LLC US 214124 4721-018062-07 10886705003655

    Patients

    Seq Age Sex Outcome Treatment
    1