BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMPION PASSER NEEDLE

    MDR report key: 5848864 · Received August 4, 2016

    Report

    Report Number
    3004086872-2016-00001
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    June 15, 2016
    Report Date
    July 22, 2016
    Manufacturer
    COORSTEK MEDICAL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUTURE PASSER USED WITH THE FAILED NEEDLES WAS RETURNED 7-8-2016. THE NEEDLES THAT BROKE WERE NOT RETURNED. VISUAL INSPECTION OF THE SUTURE PASSER REVEALED NO NON-CONFORMITIES. THE DEVICE LOOKED USED BUT HAD NO VISUAL DEVIATIONS FROM THE DESIGN OF THE PRODUCT. THE UNIT WAS TESTED FUNCTIONALLY IN A DRY ENVIRONMENT BY LOADING A NEW NEEDLE AND CYCLING THE NEEDLE THROUGH SIMULATED TISSUE. THE NEEDLE WAS CYCLED 50 TIMES THROUGH SIMULATED TISSUE WITH NO DAMAGE TO THE NEEDLE. THE NEEDLE WAS THEN DRY CYCLED WITHOUT SIMULATED TISSUE AND ADDITIONAL 16 CYCLES BEFORE THE NEEDLE TIP BROKE. THE DESIGN REQUIREMENT OF THE NEEDLE IS THAT IT WITHSTANDS 24 CYCLES BEFORE IT BREAKS. THEREFORE, THE NEEDLE MET THE DESIGN REQUIREMENTS. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT# 992658 SUTURE PASSER NEEDLE, BOX OF (B)(4). SAMPLES OF NEEDLES MANUFACTURED FROM THIS LOT WERE FATIGUE TESTED SHOWING WITH 95% CONFIDENCE THAT 99% OF THE LOT WOULD PASS THE MINIMUM REQUIREMENT OF 24 CYCLES. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUTURE PASSER LOT# 915288 AND THERE WERE NO DIMENSIONAL OR FUNCTIONAL NON-CONFORMANCES FOUND. THE INSTRUCTIONS FOR USE INCLUDED WITH THE SUTURE PASSER CAUTION THE USER TO USE UNDER DIRECT VISUALIZATION AND TO NOT USE EXCESSIVE FORCE. WHERE THE SUTURE PASSER FUNCTIONED PROPERLY DURING TESTING AND THE DEVICE HISTORY RECORD FOR NEEDLE LOT 992658 CONTAINS TESTING OF THE PRODUCT SHOWING WITH 95% CONFIDENCE THAT 99% OF THE LOT WOULD MEET THE MINIMUM 24 CYCLE REQUIREMENT, THE ROOT CAUSE IS MOST LIKELY ATTRIBUTED TO FACTORS OUTSIDE THE MANUFACTURE OR DESIGN OF THE PRODUCT. WHERE THE BROKEN NEEDLES WERE NOT RETURNED, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO USER ERROR OR USE OF THE PRODUCT IN A MANNER OTHER THAN DESCRIBED IN THE INSTRUCTIONS FOR USE INCLUDED WITH THE PRODUCT. FAILED DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6), EUROPE BUT IS BEING REPORTED DUE TO THE SAME DEVICE ALSO BEING DISTRIBUTED TO U.S. MRS. (B)(6), BIOMEDICAL ENGINEER AND RISK MANAGER AT THE CLINIC, REPORTED THE FOLLOWING EVENT (POSSIBLY TO THE (B)(6)) : "DR (B)(6) HAD A PATIENT FOR A LEFT SHOULDER CUFF. HE USED A LOAN KIT WITH A CHAMPION SUTURE PASSER AND A STRYKER RP 360° NEEDLE REF 3910-900-094, LOT# 992658, EXP 2017/10 (SINGLE USE). DURING THE INSERTION OF THE ANCHOR INTO THE SHOULDER, THE NEEDLE FRACTURED AT ITS END, LEAVING RESIDUE INTO THE PATIENT. WE RETRIEVED THE NEEDLE FRAGMENT, CHANGED THE SUTURE PASSER AND THE NEEDLE. BUT THE SAME EVENT HAPPENED AGAIN. WE THEREFORE CHANGED THE NEEDLE A THIRD TIME. RISK OF NEEDLE RESIDUE INTO THE PATIENT." ISSUE WAS NOTICED DURING A SHOULDER CUFF PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAYS. ADVERSE CONSEQUENCES RISK OF NEEDLE RESIDUE INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501315 CHAMPION PASSER NEEDLE SUTURE PASSER NEEDLE LXH COORSTEK MEDICAL 3910-900-091 992658

    Patients

    Seq Age Sex Outcome Treatment
    1 Other