BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATFIX

    MDR report key: 6942015 · Received October 11, 2017

    Report

    Report Number
    3010692967-2017-00002
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    April 10, 2017
    Report Date
    September 5, 2017
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    GAB
    PMA / PMN Number
    K072028
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: STERILE PRODUCT FROM THE REPORTED LOT WERE RETURNED FOR REVIEW/TESTING ON 5/16/2017. RESULTS/CONCLUSIONS: THE STERILE DEVICES WERE TESTED PER CURRENT CRITERIA AND MET ALL REQUIREMENTS FOR THIS SIZE/TYPE BARBED SUTURE DEVICE. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENT LOTS MET CURRENT USP AND SURGICAL SPECIALTIES MEXICO INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY IS AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. WITHOUT RECEIVING DETAILED INFORMATION REGARDING THE SURGEON'S TECHNIQUE, MATERIAL PLACEMENT IN TISSUE, PRE-OPERATIVE INSTRUCTIONS OR EVENTS A DEFINITIVE ROOT CAUSE FOR THE PARTIAL DEHISCENCE CANNOT BE DETERMINED WITH CERTAINTY. INFECTION WAS MENTIONED. HOWEVER, NO DETAILS OR CULTURE RESULTS WERE RECEIVED TO CONFIRM THIS REPORT.

    Description of Event or Problem · 1

    THIRTY FIVE DAYS POST-OPERATIVE, A HIP REPLACEMENT PROCEDURE AND INTRACUTANEOUS CLOSURE OF THE INCISION THE PATIENT PRESENTED WITH WOUND DEHISCENCE ON BOTH SIDES OF THE WOUND AND INFECTION. THE SUTURE REMAINED SITU BUT TORN OUT OF THE SKIN. NO SIGNS OF SUTURE DEGRADATION. NO ADDITIONAL DETAILS DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719207 STRATFIX 2FS 3-0 UNDYED MONODERM 30X30 GAB SURGICAL SPECIALTIES CORPORATION SXMD2B41306 MBGA340

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention