BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3844652 · Received May 20, 2014

    Report

    Report Number
    3008845715-2014-00021
    Event Type
    Other
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 19, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    UNK
    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 ACTUAL DEVICE WILL NOT BE RETURNED. RESULTS/CONCLUSIONS: THE ACTUAL DEVICE WILL NOT BE RETURNED. NO PRODUCT EVAL CAN BE PERFORMED. WITHOUT THE FINISHED GOOD ITEM/LOT NUMBER IT IS NOT CERTAIN IF THERE WERE ANY QUALITY ISSUES AGAINST THE FINISHED GOOD LOT NOT THE SUTURE COMPONENT LOT. DEHISCENCE, IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE POST PROBABLY CAUSE FOR POST OPERATIVE DEHISCENCE CAN NOT BE DETERMINED WITH CERTAINTY BASED ON THE INFO PROVIDED. REFERENCE: (B)(4). ITEM NUMBER AND FINISHED GOOD LOT NUMBER - UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE, THE SURGEON CLOSED THE WOUND WITH STRATAFIX AND PULLED IT TIGHT. HE THEN LEFT THE ROOM. THE FIRST ASSIST WAS FINISHING THE CLOSURE AND IT WAS NOTED THAT THE WOUND HAS STARTED TO UNAPPROXIMATE. 2-0 VICRYL WAS USED TO CLOSE THE WOUND WITH INTERRUPTED STITCHES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299199 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. UNK UNK

    Patients

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