BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITTNER (BLUNT) DISSECTOR, 9/16 X 1/4"

    MDR report key: 4254211 · Received November 10, 2014

    Report

    Report Number
    3005225477-2014-00023
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 30, 2014
    Report Date
    November 10, 2014
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    GDI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED TO OBTAIN THE SALES AND SIMILAR COMPLAINT INFO. (B)(4). SIMILAR REPORTS HAVE BEEN IDENTIFIED. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES. DISCREPANCIES WERE IDENTIFIED. RAW MATERIAL (B)(4), LOT NUMBER 1187971, 1189318 AND 1192423 WAS UTILIZED WITHIN THE FINISHED GOOD. THE RAW MATERIAL IS A VENDOR SUPPLIED PRODUCT. THE 2012, 2013 AND 2014 SCAR LOGS WERE REVIEWED TO IDENTIFY IF SIMILAR REPORTS WERE IDENTIFIED. THE RAW MATERIAL IS SUPPLIED TO DEROYAL BY (B)(4). THE VENDOR WAS ISSUED (B)(4). THE VENDOR HAS BEEN NOTIFIED THAT THE SAMPLE WILL NOT BE RETURNED TO DEROYAL FOR EVAL. FOLLOW-UP WAS PERFORMED ON 10/24/2014 TO ALERT THE VENDOR OF THE APPROACHING DUE DATE. THE VENDOR SUPPLIED THE RESPONSE ON 10/27/2014. DURING THE PREVIOUS INVESTIGATIONS FOR SIMILAR COMPLAINTS, THE QC COMPLAINT SPECIALIST REQUESTED ADDITIONAL INFO IN REFERENCE TO THE PREVIOUS SCAR CORRECTIVE ACTION. PREVIOUS SAMPLES WERE RECEIVED AND IT WAS IDENTIFIED THAT THE STITCHING ON THE KITTNER TO KEEP THE DEVICE CLOSED WAS NOT FULLY SECURED. THIS ALLOWED THE KITTNER TO UNRAVEL AND THE X-RAY ELEMENT TO FALL OUT. PICTURES OF THOSE SAMPLES HAVE BEEN PROVIDED TO THE VENDOR IN ADDITION TO THE ACTUAL SAMPLES. IN ADDITION TO THE VENDOR INVESTIGATION A JOINT INVESTIGATION WAS CONDUCTED WITH THE QC OF THE MFG FACILITY. AS PART OF THE OFFSHORE INVESTIGATION AN IN-HOUSE INSPECTION WAS DONE OVER THE RAW MATERIAL(B)(4) AND NO ISSUE WAS FOUND FROM LOT 1217474. ASSEMBLY PERSONNEL HAVE BEEN INFORMED OF THE ISSUE AND TO AVOID ASSEMBLY PROBLEMS, THEY HAVE TO MAKE SURE TO PLACE CORRECTLY ALL THE COMPONENTS IN THE WORK ORDER. ALSO, IF THERE IS ANY DEFECTIVE MATERIAL THEY NEED TO DOCUMENT AND SENT SAMPLES TO QC TO BE FORWARDED AS NEEDED. CORRECTION: A REPLACEMENT HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    DURING USE OF THE KITTNER DISSECTOR, SPONGE BROKE DOWN WHILE IN USE ON PT. THE BLUE X-RAY STRING FLAKED OFF IN THE PT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722988 KITTNER (BLUNT) DISSECTOR, 9/16 X 1/4" DISSECTOR, SURGICAL, GENERAL & PLAST GDI DEROYAL GUATEMALA 35935666

    Patients

    Seq Age Sex Outcome Treatment
    1