BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX

    MDR report key: 9458542 · Received December 12, 2019

    Report

    Report Number
    3010692967-2019-00042
    Event Type
    Injury
    Date Received
    December 12, 2019
    Report Date
    December 12, 2019
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    NEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A BATCH REVIEW OF THE REPORTED LOT INDICATES THERE WERE NO NON-CONFORMANCES REPORTS ISSUED FOR THE FINISHED GOODS LOT. THE PRODUCT FROM THIS FINISHED GOODS LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. STERILE SAMPLES WERE RECEIVED FOR EVALUATION AND ROOT CAUSE ANALYSIS. THE SAMPLES WERE VISUALLY INSPECTED UNDER 20X MAGNIFICATION. NO DEFECTS WERE OBSERVED. THE SAMPLES WERE THEN PULL TESTED. THE SAMPLES PASSED ALL TESTS AND MET USP AND SURGICAL SPECIALTIES CORPORATION SPECIFICATIONS WITHOUT RECEIVING PERTINENT DETAILS REGARDING THE EXPOSURE TIME OF THE DEVICES PRIOR TO USE, PRE-OPERATIVE PREPARATION OF THE DEVICE, SURGEON''S TECHNIQUE, PATIENT¿S PRE-EXISTING HEALTH CONDITIONS/ALLERGIES, POST-OPERATIVE INSTRUCTIONS, OR EVENTS THAT MAY HAVE OCCURRED AND/OR CONTRIBUTED TO THE REPORT SUTURE BREAKING AND DEHISCENCE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME WOUND DEHISCENCE IS ONE OF THE MOST COMMON COMPLICATIONS OF SURGICAL WOUNDS, INVOLVING THE OPENING OF THE SURGICAL INCISION. THERE ARE MANY CAUSES THAT CAN RESULT IN THE WOUND OPENING OR SUTURES FAILING DURING OR POST-OPERATIVE A PROCEDURE: THE PATIENT¿S HEALTH STATUS, POOR SKIN QUALITY, THIN SKIN; THE RISK IS HIGHER WITH A PATIENT WITH A WEAK IMMUNE SYSTEM, MALNUTRITION OR CHRONIC MEDICAL CONDITION. THE SURGICAL PROCEDURE ¿ THE RISK INCREASES WITH POOR SURGICAL TECHNIQUES SUCH AS IMPROPER SUTURING, OVER-TIGHTENED SUTURES OR INAPPROPRIATE TYPE OF SUTURE USED FOR A PARTICULAR PROCEDURE. OTHER FACTORS - THE RISK IS GREATER WITH SMOKING, OBESITY, PREMATURE POST-SURGERY EXERCISE, HEAVY LIFTING.

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW OF THE REPORTED LOT INDICATES THERE WERE NO NON-CONFORMANCES REPORTS ISSUED FOR THE FINISHED GOODS LOT. THE PRODUCT FROM THIS FINISHED GOODS LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. TO DATE SAMPLES HAVE NOT BEEN RETURNED FOR ROOT CAUSE EVALUATION. THERE ARE NO STERILE SAMPLES OR RETAINED SAMPLES AVAILABLE FOR TESTING. WITHOUT RECEIVING STERILE SAMPLES FOR TENSILE TESTING, MAGNIFIED PHOTO'S OF THE WOUND/INCISION, AND/OR RECEIVING PERTINENT DETAILS REGARDING THE EXPOSURE TIME OF THE DEVICES PRIOR TO USE, PRE-OPERATIVE PREPARATION OF THE DEVICE, SURGEON'S TECHNIQUE, PATIENT¿S PRE-EXISTING HEALTH CONDITIONS/ALLERGIES, POST-OPERATIVE INSTRUCTIONS, OR EVENTS THAT MAY HAVE OCCURRED AND/OR CONTRIBUTED TO THE REPORT SUTURE BREAKING AND DEHISCENCE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. WOUND DEHISCENCE IS ONE OF THE MOST COMMON COMPLICATIONS OF SURGICAL WOUNDS, INVOLVING THE OPENING OF THE SURGICAL INCISION. THERE ARE MANY CAUSES THAT CAN RESULT IN THE WOUND OPENING OR SUTURES FAILING DURING OR POST-OPERATIVE A PROCEDURE: THE PATIENT¿S HEALTH STATUS, POOR SKIN QUALITY, THIN SKIN; THE RISK IS HIGHER WITH A PATIENT WITH A WEAK IMMUNE SYSTEM, MALNUTRITION OR CHRONIC MEDICAL CONDITION. THE SURGICAL PROCEDURE ¿ THE RISK INCREASES WITH POOR SURGICAL TECHNIQUES SUCH AS IMPROPER SUTURING, OVER-TIGHTENED SUTURES OR INAPPROPRIATE TYPE OF SUTURE USED FOR A PARTICULAR PROCEDURE. OTHER FACTORS - THE RISK IS GREATER WITH SMOKING, OBESITY, PREMATURE POST-SURGERY EXERCISE, HEAVY LIFTING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR DISTRIBUTOR A PATIENT HAD A TOTAL KNEE REPLACEMENT. AFTER AN UNSPECIFIED AMOUNT OF TIME THE PATIENT RETURNED TO THE SURGEON INDICATING THE SUTURES HAD BROKEN IN THE DEEP LAYERS OF THE TISSUE. IT IS NOT KNOWN HOW THE PATIENT WAS TREATED BUT REPORTEDLY IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252545 STRATAFIX 2FS -0- PDO 24 X 24 SUTURE NEW SURGICAL SPECIALTIES CORPORATION SXPD2B420 AAEL931

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R