BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE PASSER NEEDLE

    MDR report key: 7035640 · Received November 15, 2017

    Report

    Report Number
    3004086872-2017-00011
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 15, 2017
    Manufacturer
    COORSTEK MEDICAL
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: DEVICE HISTORY RECORD REVIEW SHOWS NO NON-CONFORMANCES WITH THIS MANUFACTURE LOT. THE RECORD SHOWS THAT SAMPLE NEEDLES FROM THIS MANUFACTURE LOT WERE FATIGUE TESTED SHOWING WITH 95% CONFIDENCE THAT 100% OF THE NEEDLES WILL PASS A MINIMUM OF 24 CYCLES. DATE PRODUCT RECEIVED: 11-13-2017. DEVICE IDENTIFICATION: 3910-900-091. VISUAL INSPECTION: THE RETURNED NEEDLE WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THE TIP OF THE NEEDLE WAS BROKEN OFF. THERE WERE NO INDICATIONS THE BREAKAGE WAS A RESULT OF A MANUFACTURING ERROR. AN EXACT ROOT CAUSE OF THE BREAKAGE COULD NOT BE DETERMINED. FUNCTIONAL INSPECTION: WHERE THE NEEDLE TIP WAS ALREADY BROKEN A FUNCTIONAL INSPECTION WAS NOT PERFORMED. ADDITIONAL INVESTIGATION NOTES: A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE COMPLAINT FOUND THE NEEDLE WAS BEING PASSED THROUGH A "VERY THICK CUFF" AT THE TIME OF BREAKAGE. THIS IS THE ONLY EVIDENCE FOUND THAT MAY POSSIBLY BE THE ROOT CAUSE OF THE BREAKAGE. THIS IS A KNOWN FAILURE MODE ADDRESSED IN THE RISK MANAGEMENT FILE FOR THIS PRODUCT, AND DOES NOT EXCEED EXPECTED OCCURRENCE RATES. OCCURRENCE RATES ARE MONITORED FOR TRENDS. SERVICE HISTORY REVIEW: THE NEEDLE IS LABELED AS ONE TIME USE SO THERE HAS BEEN NO SERVICE ON THIS PRODUCT. MANUFACTURING DATE: 6-6-2017. ROOT CAUSE(S): A POSSIBLE CAUSE OF THE BREAKAGE IS THE NEEDLE WAS BEING PASSED THROUGH A "VERY THICK CUFF" AT THE TIME OF BREAKAGE. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NEEDLE TIP OF THE CHAMPION SUTURE PASSER BROKE. THE SURGEON SEARCHED FOR THE NEEDLE TIP BUT WAS UNABLE TO FIND IT. THE CUSTOMER FURTHER REPORTED THAT THE PATIENT WAS X-RAY AT THE END OF THE PROCEDURE AND THE TIP OF THE PASSER NEEDLE APPEARED TO BE BURIED IN THE CUFF AND WAS IRRETRIEVABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811768 SUTURE PASSER NEEDLE SUTURE PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 1251584

    Patients

    Seq Age Sex Outcome Treatment
    1