BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX SPIRAL

    MDR report key: 21836813 · Received April 14, 2025

    Report

    Report Number
    3010692967-2025-00014
    Event Type
    Injury
    Date Received
    April 14, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 14, 2025
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    NEW
    PMA / PMN Number
    K132268
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STERILE SAMPLES FROM THE REPORTED LOT, INCLUDING THE ACTUAL DEVICES, WERE NOT RETURNED FOR VISUAL REVIEW OR ANALYSIS. WITHOUT THE ACTUAL REPORTED DEVICES, PHOTOS OF THE DEVICES, OR DETAILED INFORMATION ON THE METHOD USED TO REMOVE THE DEVICE FROM THE PACKAGING, PREOPERATIVE PREPARATION OF THE DEVICE, OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. INDICATIONS: THE STRATAFIX ¿ SPIRAL PDO DEVICE COMPRISED OF DYED PDO IS INDICATED FOR USE IN SOFT TISSUE APPROXIMATION WHERE USE OF ABSORBABLE SUTURES IS APPROPRIATE. CONTRAINDICATIONS: THE STRATAFIX ¿ SPIRAL PDO DEVICE IS NOT TO BE USED WHERE PROLONGED (BEYOND SIX WEEKS) APPROXIMATION OF TISSUES UNDER STRESS IS REQUIRED AND IS NOT TO BE USED IN CONJUNCTION WITH OR FOR FIXATION OF PROSTHETIC DEVICES (E.G. HEART VALVES OR SYNTHETIC GRAFTS) THAT ARE NON-ABSORBABLE IN NATURE. WARNINGS: THE LOOP OF THE STRATAFIX ¿ SPIRAL PDO DEVICE FOR WOUND CLOSURE SHOULD BE DEPLOYED BY USERS FAMILIAR WITH SURGICAL PROCEDURES, TECHNIQUES AND TISSUES. PHYSICIANS SHOULD CONSIDER THE QUANTITY AND QUALITY OF TISSUE IN WHICH THE LOOP WILL BE ANCHORED. THE USE OF THIS SUTURE MAY BE INAPPROPRIATE IN HIGHLY VASCULARIZED TISSUE OR FRAGILE TISSUE THAT CANNOT WITHSTAND POTENTIAL FURTHER TIGHTENING/CONNECTION WITHIN THE LOOP. USERS SHOULD BE FAMILIAR WITH SURGICAL PROCEDURE AND TECHNIQUES INVOLVING ABSORBABLE SUTURES BEFORE EMPLOYING STRATAFIX ¿ SPIRAL PDO DEVICE COMPRISED OF PDO FOR WOUND CLOSURE, AS RISK OF WOUND DEHISCENCE MAY VARY WITH THE SITE OF APPLICATION AND THE SUTURE MATERIAL USED. PHYSICIANS SHOULD CONSIDER THE IN VIVO-PERFORMANCE (UNDER ACTIONS SECTION) WHEN SELECTING A SUTURE FOR USE IN PATIENTS. THE USE OF THIS SUTURE MAY BE INAPPROPRIATE IN ELDERLY, MALNOURISHED OR DEBILITATED PATIENTS, OR IN PATIENTS SUFFERING FROM CONDITIONS WHICH MAY DELAY WOUND HEALING. THE SAFETY AND EFFECTIVENESS OF STRATAFIX ¿ SPIRAL PDO DEVICE COMPRISED OF DYED PDO HAS NOT BEEN ESTABLISHED FOR USE IN FASCIAL CLOSURES (INCLUDING ABDOMINAL WALL, THORACIC AND EXTREMITY FASCIAL CLOSURES), GASTROINTESTINAL ANASTOMOSES, CARDIOVASCULAR TISSUE, NEURAL TISSUE, OSSEOUS TISSUE, TENDINOUS TISSUE, OPHTHALMIC SURGERY, OR FOR USE IN MICROSURGERY, THEREFORE THIS PRODUCT SHOULD NOT BE USED FOR THESE PURPOSES. AS WITH ANY FOREIGN BODY, PROLONGED CONTACT OF ANY SUTURE WITH SALT SOLUTIONS, SUCH AS THOSE FOUND IN THE URINARY OR BILIARY TRACTS MAY RESULT IN CALCULUS FORMATION. AS AN ABSORBABLE SUTURE, STRATAFIX ¿ SPIRAL PDO DEVICE COMPRISED OF DYED PDO MAY ACT TRANSIENTLY AS A FOREIGN BODY. ACCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED FOR THE MANAGEMENT OF CONTAMINATED OR INFECTED WOUNDS. AS THIS IS AN ABSORBABLE SUTURE MATERIAL, THE USE OF SUPPLEMENTAL NONABSORBABLE SUTURES SHOULD BE CONSIDERED BY THE SURGEON IN THE CLOSURE OF THE SITES WHICH MAY UNDERGO EXPANSION, STRETCHING OR DISTENTION OR WHICH MAY REQUIRE ADDITIONAL SUPPORT. CARE SHOULD BE UNDERTAKEN TO AVOID LEAVING BARBED SUTURE ENDS ADJACENT TO THE PERITONEUM IN EXTRA-PERITONEAL TISSUE CLOSURE. PRECAUTIONS: THE STRATAFIX ¿ SPIRAL PDO DEVICE CONTAINS BIDIRECTIONALLY ORIENTED BARBS TO ANCHOR TISSUES AND DOES NOT REQUIRE KNOTS TO APPROXIMATE OPPOSING EDGES OF A WOUND. TYING KNOTS ON THE BARBED SECTION OF THE MATERIAL WILL DAMAGE THE BARBS AND POTENTIALLY REDUCE THE SUTURE TENSILE STRENGTH AND BARB EFFECTIVENESS. FOR THE BIDIRECTIONAL FORCES TO BE CREATED AND FOR THE DEVICE TO FUNCTION PROPERLY, BOTH SIDES OF THE STRATAFIX ¿ SPIRAL PDO DEVICE MUST BE ENGAGED IN THE TISSUE. ADDITIONALLY, WHEN COMPLETING PLACEMENT, AN ADDITIONAL BACKSTITCH OR BITE OF TISSUE LATERAL TO THE END OF THE INCISION IS REQUIRED TO LOCK THE DEVICE IN PLACE. AVOID CONTACTING THE STRATAFIX ¿ SPIRAL PDO DEVICE AND ASSOCIATED NEEDLES WITH OTHER MATERIALS (E.G. SURGICAL GAUZE, DRAPES, ETC.) IN THE SURGICAL FIELD TO PREVENT ENSNARING ON THE BARBS. IF THE BARBS CATCH, CAREFULLY PULL THE MATERIAL IN THE OPPOSITE DIRECTION OF THE NEEDLE TO DISENGAGE IT FROM THE BARBS. CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE MATERIAL WITH SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. DO NOT PULL THE STRATAFIX ¿ SPIRAL PDO DEVICE COMPRISED OF DYED PDO OUT OF THE PACKAGE BY THE NEEDLES AS THIS CAN CAUSE THE BARBS TO CATCH ON ONE ANOTHER. DO NOT ATTEMPT TO REMOVE MEMORY IN THE POLYMER BY RUNNING FINGERS DOWN THE SUTURE MATERIAL AS THIS CAN DAMAGE THE BARBS. INFECTIONS, ERYTHEMA, FOREIGN BODY REACTIONS, TRANSIENT INFLAMMATORY REACTIONS AND IN RARE INSTANCES WOUND DEHISCENCE ARE TYPICAL OR FORESEEABLE RISKS ASSOCIATED WITH ANY SUTURE AND HENCE ARE ALSO POTENTIAL COMPLICATIONS ASSOCIATED WITH STRATAFIX ¿ SPIRAL PDO DEVICE COMPRISED OF DYED PDO. WHEN USING STRATAFIX ¿ SPIRAL PDO DEVICE COMPRISED OF DYED PDO SUBCUTANEOUSLY, THE DEVICE SHOULD BE PLACED AS DEEPLY AS POSSIBLE IN ORDER TO MINIMIZE ERYTHEMA AND INDURATION NORMALLY ASSOCIATED WITH ABSORPTION. ACCEPTABLE SURGICAL PRACTICE SHOULD BE FOLLOWED WITH RESPECT TO DRAINAGE AND CLOSURE OF INFECTED WOUNDS. TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT. RESHAPING NEEDLES MAY CAUSE THEM TO LOSE STRENGTH AND BE LESS RESISTANT TO BENDING AND BREAKING. USERS SHOULD EXERCISE CAUTION WHEN HANDLING SURGICAL NEEDLES TO AVOID INADVERTENT NEEDLE STICKS. DISCARD USED NEEDLES IN ¿SHARPS¿ CONTAINERS. ADVERSE REACTIONS: BROKEN NEEDLES MAY RESULT IN EXTENDED OR ADDITIONAL SURGERIES OR RESIDUAL FOREIGN BODIES.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025 THAT A NEEDLE BROKE INTRAOPERATIVELY. THE NEEDLE WAS SUCCESSFULLY REMOVED FROM THE SITE AND NO PATIENT INJURY WAS REPORTED; HOWEVER, INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108980 STRATAFIX SPIRAL SXPD1B401 NEW SURGICAL SPECIALTIES CORPORATION SXPD1B401 E731SBT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R