BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDEAL SUTGRASPER 60 DEG *EA

    MDR report key: 8020655 · Received October 30, 2018

    Report

    Report Number
    1221934-2018-55118
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Report Date
    June 3, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    NBH
    UDI-DI
    10886705012312
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. THE COMPLAINT CAN BE CONFIRMED. IT WAS OBSERVED THAT WHEN THE TRIGGER WAS PUSHED, THE FRONT ELBOW TUNNEL OF THE DEVICE WAS PUSHED OFF BY THE WIRE. IN THIS FORM, THE DEVICE CANNOT BE USED. HOWEVER, WHEN THE ELBOW TUNNEL WAS HELD IN PLACE AS IF IT WERE ATTACHED TO THE DEVICE AND THE TRIGGER WAS PUSHED, THE WIRE COULD BE PUSHED OUTWARD THROUGH THE ELBOW TUNNEL AS INTENDED. IT APPEARS THAT THE WELD BETWEEN THE FRONT ELBOW TUNNEL AND THE MAIN SHAFT OF THE DEVICE HAS BEEN BROKEN. A MEMBER OF NEW PRODUCT DEVELOPMENT (NPD) QUALITY WAS CONSULTED FOR FURTHER INSIGHT INTO THE REPORTED FAILURE. A NON-CONFORMANCE SEARCH WAS CONDUCTED TO INVESTIGATE ANY DEFECTS DURING PRODUCTION IDENTIFIED THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION. NO NON-CONFORMANCE WAS IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE WELD FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE AND PREVENTATIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHESE 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. UDI: (B)(4). THE EXPIRATION DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4)-INCOMPLETE. THE EXP DATE IS CURRENTLY UNAVAILABLE. THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. THE COMPLAINT CAN BE CONFIRMED. IT WAS OBSERVED THAT WHEN THE TRIGGER WAS PUSHED, THE FRONT ELBOW TUNNEL OF THE DEVICE WAS PUSHED OFF BY THE WIRE. IN THIS FORM, THE DEVICE CANNOT BE USED. HOWEVER, WHEN THE ELBOW TUNNEL WAS HELD IN PLACE AS IF IT WERE ATTACHED TO THE DEVICE AND THE TRIGGER WAS PUSHED, THE WIRE COULD BE PUSHED OUTWARD THROUGH THE ELBOW TUNNEL AS INTENDED. IT APPEARS THAT THE WELD BETWEEN THE FRONT ELBOW TUNNEL AND THE MAIN SHAFT OF THE DEVICE HAS BEEN BROKEN. A MEMBER OF NEW PRODUCT DEVELOPMENT (NPD) QUALITY WAS CONSULTED FOR FURTHER INSIGHT INTO THE REPORTED FAILURE. THE NPD MEMBER INDICATED THAT IT TAKES A SUBSTANTIAL AMOUNT OF FORCE TO SEPARATE THE ELBOW FROM THE SHAFT OF THE DEVICE, WHICH WILL ALSO DEFORM THE MAIN SHAFT OF THE DEVICE. SINCE THE DEVICE APPEARED TO HAVE NO OTHER STRUCTURAL ANOMALIES, THE NPD MEMBER INDICATED THAT THIS FAILURE MAY HAVE BEEN CAUSED BY A MANUFACTURING DEFECT. A NON-CONFORMANCE SEARCH WAS CONDUCTED TO INVESTIGATE ANY DEFECTS DURING PRODUCTION IDENTIFIED THAT MAY CONTRIBUTE TO THE COMPLAINT CONDITION. NO NON-CONFORMANCE WAS IDENTIFIED FOR THIS PART-LOT NUMBER COMBINATION. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF DEVICES WITH THE PRODUCT CODE THAT WERE RELEASED TO DISTRIBUTION. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE AND PREVENTATIVE 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 · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE IDEAL SUTGRASPER 60 DEG EA DEVICE COULD NOT BE USED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE WELD BETWEEN THE FRONT ELBOW TUNNEL AND THE MAIN SHAFT OF THE DEVICE HAD BEEN BROKEN. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED WITHOUT ANY OTHER PROBLEM; ALTHOUGH, IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS REPORTED THAT THE DEVICE WAS BRAND NEW AND FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858209 IDEAL SUTGRASPER 60 DEG *EA SUTURE/NEEDLE PASSER, REUSABLE NBH DEPUY MITEK LLC US L790103 10886705012312

    Patients

    Seq Age Sex Outcome Treatment
    1