BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 4425354 · Received January 14, 2015

    Report

    Report Number
    3008845715-2015-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 12, 2015
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED HAS NOT BEEN RECEIVED. RELEVANT PORTION OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES PUERTO RICO INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE LOT REPORTED. NEEDLE SUPPLIER, WHICH IS OUR CUSTOMER AS WELL, WAS CONTACTED TO VERIFY IF THERE WERE ANY QUALITY ISSUES RELATED TO THE NEEDLE BATCH USED IN THE MANUFACTURING OF THE REPORTED LOT REVIEWED. AT THE TIME OF THIS REPORT INFORMATION FROM THE SUPPLIER HAS NOT MADE AWARE OF THIS COMPLAINT FOR A CONTINUED INVESTIGATION. REFERENCE: COMPLAINT #6443 (ETHICON COMPLAINT #(B)(4)), ITEM #SXPD2B409 STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE, 2MH - 1 - PDO 14X14, LOT MBQJ420.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "NEEDLE BROKE DURING SUTURING". THER WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31565 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B409 MBQJ420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE