BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 3919506 · Received June 13, 2014

    Report

    Report Number
    3008845715-2014-00023
    Event Type
    Other
    Date Received
    June 13, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO 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

    IT IS UNK IF THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED IS AVAILABLE. METHOD: IT IS UNK IF THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED IS AVAILABLE. PER ELECTRONIC COMMUNICATION FROM THE CUSTOMER, IT WAS STATED THAT ONLY TWO LOTS WERE INVOLVED, CLARIFICATION FROM THE CUSTOMER IS PENDING. HOWEVER, THREE SUSPECT LOTS WERE PROVIDED; MBHW470, MBMZ760, MBMZ770. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED. FINISHED GOOD PRODUCTS WERE RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE PRODUCT FROM THESE FINISHED GOOD LOTS AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES PUERTO RICO INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE SUSPECT FINISHED GOOD LOTS. ON (B)(4) 2014, (B)(4) BOXES OF LOT MBHW470, (B)(4) BOXES OF LOT MBMZ760 AND (B)(4) BOX OF MBMX770, ALL UNOPENED WERE RECEIVED AT OUR PREMISES. THE RESULTS OF THE EVAL PERFORMED DEMONSTRATED THAT THE PRODUCT WAS WITHIN SPECIFICATION. DEHISCENCE, IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE DEHISCENCE CAN NOT BE DETERMINED WITH CERTAINTY DUE TO ALL SAMPLES EVALUATED WERE FOUND ACCEPTABLE. REF: COMPLAINT # (B)(4)(ETHICON COMPLAINT # (B)(4)). ITEM # SXPD2B405 STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE - 2CTX #2 PDO 36 X 36, LOT UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SUTURE TORE APART LEAVING THE WOUND NO OTHER OPTION THAN TO BREAK OPEN. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. REF. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349528 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B405 UNK

    Patients

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