BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3397168 · Received October 9, 2013

    Report

    Report Number
    3008845715-2013-00018
    Event Type
    Other
    Date Received
    October 9, 2013
    Report Date
    October 7, 2013
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Product Problem
    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. THEREFORE, NO TESTING CAN BE PERFORMED. METHOD, CONCLUSIONS: THE DEVICE WILL NOT BE RETURNED. NO PRODUCT EVALUATION CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT WAS REC'D 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. INFECTION AND DEHISCENCE, ARE KNOW RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR OPERATIVE INFECTION AND DEHISCENCE CAN NOT BE DETERMINED WITH CERTAINTY BASED ON THE INFO PROVIDED. REFERENCE: COMPLAINT # (B)(4) (PATIENT 2). ITEM # SXPD2B408 STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE. 2MH -0- PDO 24 X 24, FINISHED GOOD LOT ME03720.

    Description of Event or Problem · 1

    SURGEON NOTICED INFECTION IN PT THAT HAVE HAD TOTAL KNEE REVISIONS. AT 4-5 WEEKS POST OPERATION SURGEON NOTICED LITTLE OPENINGS IN THE SKIN WHERE SUTURE WAS STICKING OUT CAUSING REDNESS AND FLUID BUILD UP. WOUND WAS TREATED WITH ANTIBIOTICS. REF PR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512939 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B408 ME03720

    Patients

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