BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SUTURE

    MDR report key: 10800336 · Received November 6, 2020

    Report

    Report Number
    3010692967-2020-00035
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    October 21, 2020
    Report Date
    November 5, 2020
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT/ITEM NUMBER HAS NOT BEEN PROVIDED AND THEREFORE WE ARE UNABLE TO PERFORM A LOT REVIEW TO DETERMINE IF THERE WERE ANY NON-CONFORMANCE REPORTS ISSUED FOR THE PARTICULAR LOT NO PHOTOGRAPHS OR SAMPLES WERE AVAILABLE FOR REVIEW. WITHOUT THE FINISHED GOOD LOT NUMBER, RETAINED SAMPLES COULD NOT BE REVIEWED. IF SAMPLES, PHOTOS OR ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THE SAMPLES OR INFORMATION WILL BE REVIEWED AND ADDED TO THE FILE. A REVISED REPORT WILL BE SUBMITTED AT THAT TIME. WITHOUT RECEIVING THE PERTINENT INFORMATION REGARDING THE LOT OF THE DEVICES USED, SIZE/TYPE OF SUTURE MATERIAL, RECEIVING ACTUAL PRODUCTS TO TEST/REVIEW, RECEIVING PHOTOS OF THE DEHISCED INCISION, DETAILS REGARDING POST-OPERATIVE EVENTS THAT MAY HAVE OCCURRED WHICH MAY HAVE ATTRIBUTED TO INJURY OR THE DEHISCENCE OF THE INCISION, DETAILS OF THE PROCEDURE PERFORMED, PLACEMENT OF THE DEVICE, METHOD UTILIZED TO ANCHOR THE DEVICE IN THE TISSUE, QUALITY OF THE PATIENT'S TISSUE UTILIZED FOR ANCHORING THE DEVICE, THE PATIENT¿S HEALTH STATUS OR THE SURGEON'S EXPERIENCE AND TECHNIQUE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONFIRMED WITH CERTAINTY. AS STATED IN THE IFU FOR THE DEVICES, ¿ADVERSE EVENTS INCLUDING WOUND DEHISCENCE AND REACTIONS ARE COMMON RISKS/COMPLICATIONS OF ANY SURGICAL PROCEDURE. THERE ARE MANY CAUSES THAT CAN RESULT IN THE WOUND OPENING, SUTURES FAILING OR REACTION, INFECTION, ABSCESS/LEAKAGE 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 AND HEAVY LIFTING. ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THIS DEVICE MAY INCLUDE, WOUND DEHISCENCE, FAILURE TO PROVIDE ADEQUATE WOUND SUPPORT IN CLOSURE OF THE SITE WHERE EXPANSION, STRETCHING OR DISTENSION OCCUR, FAILURE TO PROVIDE ADEQUATE WOUND SUPPORT IN ELDERLY, MALNOURISHED OR DEBILITATED PATIENTS OR IN PATIENTS SUFFERING FROM CONDITION WHICH MAY DELAY WOUND HEALING, INFECTION, MINIMAL ACUTE INFLAMMATORY TISSUE REACTION, LOCALIZED IRRITATION WHICH SKIN SUTURES ARE LEFT IN PLACE FOR GREATER THAN 7 DAYS, SUTURE EXTRUSION AND DELAYED ABSORPTION IN TISSUE WITH POOR BLOOD SUPPLY, CALCULI FORMATION IN URINARY AND BILIARY TRACTS WHEN PROLONGED CONTACT WITH SALT SOLUTIONS SUCH AS URINE AND BILE OCCURS AND TRANSITORY LOCAL INFECTION AT THE WOUND SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP OF OUR DISTRIBUTOR THAT FOLLOWING A FEMOROPOPLITEAL BYPASS THE SURGEON REPORTED THAT THE PATIENT RETURNED WITH DEHISCENCE AND SUTURE SPITTING TWO WEEKS POST OP. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266848 STRATAFIX SUTURE UNKNOWN STRATAFIX PGA-PCL SUTURE GAM SURGICAL SPECIALTIES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R