BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3772298 · Received March 19, 2014

    Report

    Report Number
    3008845715-2014-00009
    Event Type
    Other
    Date Received
    March 19, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 17, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH
    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 HAS NOT BEEN RECEIVED. METHOD/RESULTS/CONCLUSIONS: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED HAS NOT BEEN RECEIVED. NO PRODUCT EVALUATION 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 SPECIALITIES PUERTO RICO INC REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. AT THE TIME OF THIS REPORT SAMPLES HAVE NOT BEEN RECEIVED. UPON RECEIPT OF SAMPLES A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. 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 INFORMATION PROVIDED. REFERENCE: COMPLAINT #(B)(4) ITEM #SXPD2B405 STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE 2CTX #2 PDO 36 X 36, LOT MBMZ770.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT 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. PT WAS RETURNED TO THE OPERATING ROOM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165083 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH SXPD2B405 MBMZ770

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE