BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3410606 · Received September 23, 2013

    Report

    Report Number
    3008845715-2013-00016
    Event Type
    Other
    Date Received
    September 23, 2013
    Date of Event
    August 26, 2013
    Report Date
    September 23, 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. METHOD: THE ACTUAL DEVICE WILL NOT BE RETURNED. RESULTS/CONCLUSIONS: THE ACTUAL DEVICE WILL NOT BE RETURNED. NEEDLE SUPPLIER WHICH IS OUR CUSTOMER AS WELL WAS CONTACTED TO VERIFY IF THERE WERE ANY QUALITY ISSUES RELATED TO THE NEEDLE BATCH. AS OF THE DAY OF THIS REPORT, NO INFORMATION HAS BEEN RECEIVED FROM SUPPLIER. 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. CUSTOMER WILL RETURN FOUR (4) UNOPENED PIECES FOR EVALUATION PURPOSES. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF NEEDLE BROKE DURING A TOTAL KNEE REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES. AT A LATER DATE, ADDITIONAL INFORMATION WAS RECEIVED INFORMING THAT NEEDLE FALL INTO THE PATIENT, HOWEVER X-RAYS WERE TAKEN AND NOTHING SEEN. NO PLAN TO REMOVE THE NEEDLE AT THIS POINT. REF. PR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479080 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B405 MBMF620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention