BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3772258 · Received March 26, 2014

    Report

    Report Number
    3008845715-2014-00011
    Event Type
    Other
    Date Received
    March 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 21, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH PR 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. METHOD: THE ACTUAL DEVICE WILL NOT BE RETURNED. RESULTS/CONCLUSIONS: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. NO PRODUCT EVAL CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT AS WELL AS THE SUTURE COMPONENT THESE 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, MANUFACTURING AND THE FINAL INSPECTION PROCESS. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. DEHISCENCE, IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE DEHISCENCE CAN NOT BE DETERMINED WITH CERTAINTY BASED ON THE INFO PROVIDED. (B)(4). ITEM NUMBER: SXPD2B202 STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE 20S-8 #2 PDO 36X36, LOT ME01710.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PATIENT CAME BACK TO THE OPERATING ROOM OVER THE WEEKEND AND THE SUTURE THAT WAS USED IN THE JOINT CAPSULE WAS UNRAVELED UPON INSPECTION. THE SURGEON USED ETHIBOND. PATIENT WAS RETURNED TO THE OPERATING ROOM." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177971 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH PR INC. SXPD2B202 ME01710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA