BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMPION PASSER NEEDLE

    MDR report key: 6946646 · Received October 12, 2017

    Report

    Report Number
    3004086872-2017-00009
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 18, 2017
    Report Date
    October 12, 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

    THIS INFORMATION IS PROVIDED AS A FOLLOW-UP TO THE ORIGINAL REPORT BECAUSE THE PRODUCT WAS RETURNED FOR EVALUATION. THE NEEDLE WAS RETURNED 11-12-2017. VISUAL INSPECTION OF THE NEEDLE SHOWS IT DOES NOT HAVE A BEND CONSISTENT WITH OTHER NEEDLES THAT HAVE PASSED THROUGH A SUTURE PASSER. THERE ARE SOME VERY SLIGHT REVERSE BENDS CONSISTENT WITH THE NEEDLE COMING IN CONTACT WITH SOMETHING HARD. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED BUT THE REVERSE BENDING IS CONSISTENT WITH RESULTS OF A NEEDLE COMING INTO CONTACT WITH SOMETHING HARD. THIS IS CONSISTENT WITH THE ORIGINAL POSSIBLE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: DEVICE HISTORY RECORD REVIEW SHOWS NO NON-CONFORMANCE ASSOCIATED WITH THIS MANUFACTURE LOT OF NEEDLES. SAMPLE NEEDLES FROM THIS MANUFACTURE LOT WERE FATIGUE TESTED AND DATA SHOWS WITH 95% CONFIDENCE THAT 99.9% OF THE LOT WOULD PASS A MINIMUM OF 24 CYCLES. DATE PRODUCT RECEIVED: PRODUCT WAS NOT RETURNED. DEVICE IDENTIFICATION: 3910-900-091. VISUAL INSPECTION: WHERE PRODUCT WAS NOT RETURNED A VISUAL INSPECTION WAS NOT PERFORMED. FUNCTIONAL INSPECTION: WHERE PRODUCT WAS NOT RETURNED A FUNCTIONAL INSPECTION WAS NOT PERFORMED. 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: THERE HAS BEEN NO SERVICE ON THIS DEVICE. ROOT CAUSE(S): WHERE THE DEVICE WAS NOT RETURNED AN EXACT ROOT CAUSE COULD NOT BE CONFIRMED. WHERE THE DEVICE HISTORY RECORD REVIEW SHOWS NO NON-CONFORMANCES WITH THIS MANUFACTURE LOT AND FATIGUE TESTING RESULTS THAT SHOW WITH 95% CONFIDENCE THAT 99.9% WOULD PASS A MINIMUM OF 24 CYCLES THE ROOT CAUSE IS MOST LIKE DUE TO SOMETHING OTHER THAN MANUFACTURING. IT IS POSSIBLE THE NEEDLE CAME IN CONTACT WITH SOMETHING HARD, SUCH AS BONE, DURING USE.

    Description of Event or Problem · 1

    (B)(6), THE ORTHOPEDIC SURGEON AT THE HOSPITAL SENT A LETTER WHERE THE FOLLOWING EVENT IS REPORTED: " DURING A SURGERY, WHEN SUTURING A TENDON, THE NEEDLE BROKE." COUNTRY OF EVENT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723746 CHAMPION PASSER NEEDLE SUTURE PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 1270136

    Patients

    Seq Age Sex Outcome Treatment
    1