BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 5007287 · Received August 13, 2015

    Report

    Report Number
    3008845715-2015-00076
    Event Type
    Other
    Date Received
    August 13, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 12, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT INVOLVED W/THE INCIDENT REPORTED HAS NOT BEEN RETURNED. METHOD/RESULTS/CONCLUSIONS: THE ACTUAL PRODUCT INVOLVED W/THE INCIDENT REPORTED HAS NOT BEEN RETURNED. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED, THEREFORE, NO PRODUCT EVALUATION CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT AS WELL AS THE SUTURE COMPONENT WERE RECEIVED INTO INVENTORY W/OUT QUALITY ISSUES. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES PUERTO RICO INC. REQUIREMENTS THROUGHOUT THE INCOMING, MFR'G AND THE FINAL INSPECTION PROCESSES. DEHISCENCE IS A KNOWN RISK W/ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE DEHISCENCE CAN NOT BE DETERMINED W/CERTAINTY BASED ON THE INFORMATION PROVIDED. ITEM #SXPD2B411 STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED: "THE SURGEON OPENED THE WOUND AND FOUND THE SUTURE WAS BROKEN INTO 4 PARTS. THE SURGEON HAS TO MAKE THE SECOND SURGERY. THE PATIENT IS STILL IN THE HOSPITAL FOR FURTHER OBSERVATION. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536042 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B411 MCMGH030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA