BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 4361033 · Received December 19, 2014

    Report

    Report Number
    3008845715-2014-00079
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    December 4, 2014
    Report Date
    December 17, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED HAS NOT BEEN RECEIVED. NO PRODUCT EVALUATION CAN BE PERFORMED AT THIS TIME. NO INVENTORY AVAILABLE FOR THE LOT REPORTED. 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 SPECIALTIES (B)(4) INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NEEDLE SUPPLIER, WHICH IS OUR CUSTOMER AS WELL, WAS CONTACTED TO VERIFY IF THERE WERE ANY QUALITY ISSUES RELATED TO THE NEEDLE BATCHES USED IN THE MANUFACTURING OF THE LOTS REVIEWED. AS OF THE DAY OF THIS REPORT, INFORMATION HAS NOT BEEN RECEIVED FROM SUPPLIER. THE NEEDLE SUPPLIER HAS BEEN MADE AWARE OF THIS COMPLAINT FOR A CONTINUED INVESTIGATION. UPON RECEIPT OF SAMPLES, WE WILL PROVIDE A FOLLOW-UP CONTAINING RESULTS OF THE EVALUATION. (B)(4). ITEM #SXPD2B40505 STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE - 2CTX #2 PDO 36X36, LOT MCMG620.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A TOTAL HIP REPLACEMENT, THE TIP OF THE NEEDLE BROKE OFF DURING THE PROCEDURE. THE NEEDLE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837675 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B40505 MCMG620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE