BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SUTURE

    MDR report key: 12095898 · Received June 30, 2021

    Report

    Report Number
    3010692967-2021-00024
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 8, 2021
    Report Date
    August 5, 2021
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    NEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES WERE VISUALLY REVIEWED AND PULL TESTED. THE RESULTS MEET THE SPECIFICATION INCLUDING USP TENSILE STRENGTH REQUIREMENTS FOR A #2 PDO DEVICE.

    Additional Manufacturer Narrative · 0

    THE INSTITUTION AND THE DISTRIBUTOR¿S SALES REPRESENTATIVE WERE NOT SURE WHICH LOT NUMBER IS ASSOCIATED WITH THE EVENT. THE SECOND POSSIBLE LOT NUMBER ASSOCIATED WITH THE EVENT IS: LOT NUMBER: AAGR611. UDI CODE:(B)(4). BATCH REVIEWS OF THE FINISHED GOOD LOTS AND COMPONENTS CONFIRMED THERE WERE NO QUALITY ISSUES NOTED THROUGHOUT THE INCOMING INSPECTION, MANUFACTURING, STERILIZATION, IN-PROCESS, OR FINAL INSPECTION PROCESS. THE EXACT LOT NUMBER FOR THIS FOLLOW-UP REPORT IS NOT KNOWN BUT OUR DISTRIBUTOR¿S SALE REPRESENTATIVE DID RETURN TO THE INSTITUTION IN AN ATTEMPT TO RETRIEVE THE INFORMATION. UPON REVIEW OF THE INVENTORY THE SALES REPRESENTATIVE WAS ABLE TO NARROW THE LOT NUMBER DOWN TO THE TWO FOLLOWING LOT NUMBERS IN THE CUSTOMERS¿ EXISTING INVENTORY, AAGR611 AND AAHL227. THE SALES REPRESENTATIVE WAS ALSO ABLE TO OBTAIN INFORMATION FROM THE SURGEON WHO INDICATED THE PATIENT HAD NO PRE-EXISTING CONDITIONS. THE INCISION WAS WASHED OUT IN THE O.R. WITH IRRISEPT AND SALINE. THE PATIENT RETURNED TO LIMITED PT AND NPO ANTIBIOTICS FOR 10 DAYS AFTER THE SECOND SURGERY. NO CULTURE RESULTS WERE PROVIDED AT THIS TIME.

    Description of Event or Problem · 0

    PATIENT HAD TO GO BACK TO THE OR TO GET WASHED OUT AND CLOSED WITH NON-STRATAFIX SUTURE. WOUND WAS CLEANED IN THE OR WITH IRRISEPT AND SALINE. SLOW RETURN TO LIMITED PT AND NPO ANTIBIOTICS FOR 10 DAYS AFTER 2ND SURGERY.

    Additional Manufacturer Narrative · 1

    A LOT NUMBER WAS NOT REPORTED SO A BATCH REVIEW OF THE FINISHED GOOD LOT AND COMPONENTS COULD NOT BE REVIEWED TO DETERMINE IF THERE WERE QUALITY ISSUES NOTED THROUGHOUT THE INCOMING INSPECTION, MANUFACTURING, IN-PROCESS OR FINAL INSPECTION PROCESS. IT WAS REPORTED BY THE SALE REPRESENTATIVE OF OUR DISTRIBUTOR THE PATIENT¿S INCISION HAD RUPTURED WHEN THE PATIENT¿S WAS DOING FLEXION¿S IN PHYSICAL THERAPY AFTER A TOTAL KNEE REPLACEMENT. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE PATIENT¿S CURRENT STATUS AND/OR THE CLOSURE OF THE WOUND. 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 AND A FOLLOW-UP REPORT WILL BE FILED. WITHOUT RECEIVING A FINISHED GOOD LOT SO MANUFACTURED RECORDS COULD BE REVIEWED, RECEIVING STERILE DEVICES TO TENSILE TEST, MAGNIFIED PHOTO'S OF THE RUPTURED INCISION, OR RECEIVING DETAILED INFORMATION REGARDING THE PRE-OPERATIVE PREPARATION OF THE DEVICES, PLACEMENT OF THE DEVICE IN THE TISSUE, SURGEON¿S TECHNIQUE, THE PATIENT¿S HEALTH STATUS AND SPECIFICS, OR QUALITY OF THE TISSUE, 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. THE WARNING IN THE IFU STATES, ¿THIS AN ABSORBABLE MATERIAL, THE USE OF SUPPLEMENTAL NON ABSORBABLE SUTURES SHOULD BE CONSIDERED BY THE SURGEON IN THE CLOSURE OF SITES WHICH MAY UNDERGO EXPANSION, STRETCHING OR DISTENTION OR WHICH MAY REQUIRE ADDITIONAL SUPPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT POST-OP OF A TOTAL KNEE REPLACEMENT PROCEDURE THAT POST OP DAY ONE THE PATIENT WAS DOING PHYSICAL THERAPY FLEXIONS AND THE CENTER OF THE INCISION RUPTURED. UNKNOWN AS TO HOW THE INCISION WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989199 STRATAFIX SUTURE 20S-8 #2 PDO 36 X 36 NEW SURGICAL SPECIALTIES SXPD2B202 AAHL227

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R