BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 4482697 · Received February 2, 2015

    Report

    Report Number
    3008845715-2015-00006
    Event Type
    Other
    Date Received
    February 2, 2015
    Date of Event
    December 9, 2014
    Report Date
    January 30, 2015
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED; HOWEVER, A REPRESENTATIVE SAMPLE WAS RECEIVED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT AS WELL AS THE SUTURE COMPONENT WERE 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, MFG AND FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. ON 1/21/2015 ONE UNOPENED SAMPLE OF ITEM (B)(4) OF LOT MBZK690 WAS RECEIVED AT OUR PREMISES. A DIMENSIONAL INSPECTION AS WELL AS TENSILE TESTING WAS PERFORMED DEMONSTRATING THAT THE SAMPLE MET OUR ACCEPTANCE CRITERIA. DEHISCENCE IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE DEHISCENCE CANNOT BE DETERMINED WITH CERTAINTY DUE TO THE SAMPLE EVALUATED BEING UNACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THERE WERE WOULD DEHISCENCE AFTER SUTURING WITH STRATAFIX DEVICES. TWO EVENTS OCCURRED IN JOINT CAPSULE LAYER." ADDITIONAL INFO RECEIVED ON 01/18/2015: FOR PT 2 WHO HAS RED INFLAMMATORY SKIN, THE SBC COUNT IS NORMAL SO THEY INTERPRET THAT THERE WAS NO INFECTION. THEN THEY DIAGNOSED THAT THERE WAS INFLAMMATION CAUSED BY THE JOINT FLUID LEAKAGE. THE REASON IS THE BREAKAGE OF THE (B)(4) (STRATAFIX PDO USP 1) THAT WAS SUTURED AT THE JOINT CAPSULE (THEY CUT TO THAT AREA AND SAW SUTURE WAS BROKEN). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75054 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B405 MBNA110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA