BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3557129 · Received January 2, 2014

    Report

    Report Number
    3008845715-2013-00045
    Event Type
    Other
    Date Received
    January 2, 2014
    Date of Event
    November 29, 2013
    Report Date
    December 30, 2013
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K072028
    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. METHOD - THE DEVICE WILL NOT BE RETURNED. RESULTS/CONCLUSIONS: THE DEVICE WILL NOT BE RETURNED, HOWEVER, SAMPLES WILL BE SENT FOR EVAL PURPOSES. NO PRODUCT EVAL CAN BE PERFORMED AT THIS MOMENT. RELEVANT PORTIONS 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, MFG AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. AT THE TIME OF THIS REPORT, SAMPLES HAVE NO BEEN RECEIVED. UPON RECEIPT OF SAMPLES, A F/U REPORT WILL BE SUBMITTED ONCE THE EVAL IS COMPLETED. DEHISCENCE AND INFECTION, ARE KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE INFECTION AND DEHISCENCE CAN NOT BE DETERMINED WITH CERTAINTY BASED ON THE INFO PROVIDED. REF COMPLAINT # (B)(4) (ETHICON'S COMPLAINT # (B)(4)). ITEM # SXMDB412 STRATAFIX SPIRAL PGA-PCL KNOTLESS TISSUE CONTROL DEVICE, 2FS 2-0 UNDYD MONODERM 30X30, FINISHED GOOD LOT MBVN200.

    Description of Event or Problem · 1

    PLASTIC SURGERY CASE, ONE WEEK LATER THE PT WAS ADMITTED BACK INTO THEATRE WITH DEHISCENCE ON ONE BUTTOCK. THE DEHISCENCE WAS ONLY IN THE MIDDLE OF THE INCISION. THE ENDS WERE APPROXIMATED AND HEALING. AFTER DEBRIDEMENT IT WAS NOTICED THAT THE STRATAFIX SUTURE HAD SNAPPED AT THE MID POINT. WHERE THE SUTURE SNAPPED THE INCISION OPENED UP AND BECAME INFECTED. REF PR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXMD2B412 MBVN200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention NONE MADE AVAILABLE