BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURE PASSER

    MDR report key: 5956478 · Received September 16, 2016

    Report

    Report Number
    3004086872-2016-00003
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Date of Event
    August 22, 2016
    Report Date
    September 16, 2016
    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

    DATE PRODUCT RECEIVED: UPON NOTIFICATION OF COMPLAINT IT WAS COMMUNICATED THE PRODUCT WOULD NOT BE RETURNED. (B)(4). VISUAL INSPECTION: WHERE PRODUCT WAS NOT RETURNED A VISUAL INSPECTION COULD NOT BE COMPLETED. FUNCTIONAL INSPECTION: WHERE PRODUCT WAS NOT RETURNED A FUNCTIONAL INSPECTION COULD NOT BE COMPLETED. ADDITIONAL INVESTIGATION NOTES: DEVICE HISTORY RECORD REVIEW SHOWED NEEDLES, 3910-900-091, MANUFACTURED UNDER LOT 992658 MET THE PRINT REQUIREMENT OF 95% CONFIDENCE THAT 99% OF THE LOT WOULD MEET A MINIMUM OF 24 CYCLES WITH 95% CONFIDENCE THAT 99.9% WOULD MEET THE 24 CYCLE MINIMUM. SERVICE HISTORY REVIEW: THERE HAS BEEN NO SERVICE ON THIS PRODUCT. ALLEGED PROBLEM CONFIRMED: WHERE PRODUCT WAS NOT RETURNED THE ALLEGED PROBLEM COULD NOT BE CONFIRMED. ACTUAL FAILURE MODE(S): NEEDLE BROKE AT TIP. ROOT CAUSE(S): WHERE THE PRODUCT WAS NOT RETURNED THE ROOT CAUSE COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE INCLUDED WITH THE PRODUCT CONTAIN INSTRUCTIONS THAT THE SUTURE PASSER MUST BE USED UNDER DIRECT VISUALIZATION AND USE OF EXCESSIVE FORCE TO GRASP TISSUE, OR EXCESSIVE SIDE LOADING OF THE JAW MAY CAUSE INSTRUMENT BREAKAGE OR PATIENT INJURY. IN THE RARE EVENT OF DEVICE BREAKAGE, FRAGMENTS CAN BE LOCATED VISUALLY OR BY USE OF RADIOGRAPHIC IMAGING EQUIPMENT AND REMOVED MANUALLY THROUGH THE INCISION SITE. CAPA OPENED FOR ACTUAL FAILURE MODE: WHERE THE PRODUCT WAS NOT RETURNED A ROOT CAUSE COULD NOT BE DETERMINED. DUE TO THIS A CORRECTIVE ACTION WILL NOT BE IMPLEMENTED. TRENDS FOR THE REPORTED NON-CONFORMANCE WILL BE MONITORED. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    ALLEGED PROBLEM(S): CHAMPION RP 360 NEEDLE TIP BROKE OFF DURING USE IN ROTATOR CUFF SX. TIP WAS LOCATED AND REMOVED FROM PT AFTER 20 MINUTES. RADIO GRAFT SHOWED ALL PIECES WERE REMOVED. CASE CONTINUED WITHOUT ISSUE WITH NEW RP 360 NEEDLE. PRODUCT WILL NOT BE RETURNED. PROBLEM NOTED AFTER DEPLOYMENT PROBLEMS OF SUTURE THROUGH CHAMPION SUTURE PASSER STRAIGHT CAPTURE. TIP FOUND QUICKLY AND REMOVED. TWENTY MINUTE DELAY TO CASE. NO ADVERSE CONSEQUENCES TO PATIENT. EVENT OCCURRED IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607973 SUTURE PASSER SUTURE PASSER NEEDLE GAB COORSTEK MEDICAL 3910-900-091 992658

    Patients

    Seq Age Sex Outcome Treatment
    1