STRATAFIX SXPP1A409Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031227729), received between Nov 16, 2018 and Sep 24, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a right total hip replacement surgery on (b)(6) 2026 and a barbed suture was used. The patient was admitted due to developmental dysplasia of the right hip joint and underwent total hip replacement surgery on the right side. The doctor used suture during the operation, and the procedure went smoothly. After the surgery, the patient did not exercise and clean the affected hip joint in a timely manner, and did not effectively protect the affected hip joint. The incision was not properly cleaned and protected. On (b)(6) 2026, the patient and their family came to the outpatient department of the hospital for further treatment. The outpatient department admitted the patient with a diagnosis of "poor wound healing after surgery". After admission, relevant examinations were completed, and symptomatic supportive treatment such as anti infection was given to the patient. On (b)(6) 2026, under general anesthesia, a right hip skin and subcutaneous necrotic tissue resection and debridement surgery, as well as a right hip partial prosthesis revision surgery, were performed. The surgical process was smooth and the patient's condition was steadily controll

  Patient problems: Impaired Healing; Necrosis

  MAUDE report 50889589 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cellulitis; Discomfort; Purulent Discharge

  MAUDE report 50820432 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURES WERE BROKEN REPEATEDLY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365901 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR SPINE POSTERIOR ROBOT ASSISTED DISCECTOMY, DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. THE PATIENT WAS ADMITTED WITH LUMBAR DISC HERNIATION AND UNDERWENT ROUTINE PREOPERATIVE EXAMINATIONS TO RULE OUT SURGICAL CONTRAINDICATIONS. THE PATIENT UNDERWENT SURGERY AND THE DOCTOR USED A FUSION CAGE FOR INTERBODY BONE GRAFTING DURING THE OPERATION. INTRAOPERATIVE USE OF FLUID GELATIN TO STOP BLEEDING. THE PATIENT WAS GIVEN NUTRITIONAL SUPPORT AND ANTI INFECTIVE TREATMENT AFTER SURGERY, AND REMOVED THE WOUND DRAINAGE TUBE WHEN THE DRAINAGE VOLUME DECREASES. POST-OP, THE PATIENT EXPERIENCED POOR WOUND HEALING AND WOUND SECRETION. ON THE (B)(6) DAY AFTER SURGERY, THE PATIENT FOUND A SMALL AMOUNT OF YELLOW WHITE PURULENT FLUID OOZING OUT FROM THE WOUND DURING DRESSING CHANGE, AND THE WOUND PARTIALLY CRACKED, WITH POOR WOUND HEALING. ON THE (B)(6) DAY AFTER SURGERY, THE PATIENT WAS READMITTED AND THE DOCTOR PRESCRIBED DAILY DRESSING CHANGES. BASED ON THE RESULTS OF METAGENOMIC TESTING, THE PATIENT CONTINUED WITH ANTI INFECTIVE TREATMENT. ADJUST THE TREATMEN

  Patient problems: Impaired Healing; Purulent Discharge; Wound Dehiscence

  MAUDE report 24912098 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE SUBCUTANEOUS LAYER, THE NEEDLE BENT AFTER PROBABLY 10 CM. AND THE TIP BROKE WHILE MANIPULATION WITH NEEDLE HOLDER. THE SURGERY WAS NOT DELAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726455 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE SUBCUTANEOUS LAYER, THE NEEDLE BENT AFTER PROBABLY 10 CM. AND THE TIP BROKE WHILE MANIPULATION WITH NEEDLE HOLDER. THE SURGERY WAS NOT DELAYED. ANOTHER LIKE DEVICE WAS USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726451 ↗
• MalfunctionJul 16, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DID THREAD LIFTING SURGERY, AND FEEDBACK POSTOPERATIVE FACIAL SWELLING, UNEVEN AND SUSPECT THE BARB WAS NOT HANGED INTO TISSUE. AND SUSPECT THE SUTURE IS SXPP1A409 OR SXPP1A101. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Swelling/ Edema

  MAUDE report 22523244 ↗
• MalfunctionJul 16, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLASTIC SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DID THREAD LIFTING SURGERY, AND FEEDBACK POSTOPERATIVE FACIAL SWELLING, UNEVEN AND SUSPECT THE BARB WAS NOT HANGED INTO TISSUE. AND SUSPECT THE SUTURE IS SXPP1A409 OR SXPP1A101. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Swelling/ Edema

  MAUDE report 22523199 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT TREATMENT FOR A FRACTURE OF THE RIGHT TIBIAL PLATEAU ON (B)(6)2024 AND BARBED SUTURE WAS USED. THE PATIENT WAS DISCHARGED SMOOTHLY. ON THE 9TH DAY AFTER SURGERY, THE PATIENT WAS READMITTED DUE TO POOR WOUND HEALING. ON THE 17TH DAY AFTER SURGERY, A NECROTIC TISSUE RESECTION AND DEBRIDEMENT WERE PERFORMED, AND THE BLOODY EXUDATE WAS REDUCED. THE WOUND WAS NOT SUTURED AND THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Necrosis

  MAUDE report 21171678 ↗
• MalfunctionJan 30, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THE NEEDLE BENT AND GOT BROKEN WHILE USING IN ABDOMINAL WALL AT PERITONEUM. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16264631 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE NEEDLE WAS BROKEN AT THE MIDDLE OF THE BODY PART DURING CONTINUOUS SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106277 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT CRANIOTOMY BRAIN TUMOR RESECTION PROCEDURE ON (B)(6) 2018 AND BARBED SUTURE WAS USED DURING CLOSURE. THE PATIENT WAS DISCHARGED (B)(6) FROM THE FACILITY. THE PATIENT EXPERIENCED UNKNOWN SYMPTOMS AND WAS DIAGNOSED WITH AN ABSCESS ON UNKNOWN DATE AND WOUND DEHISCENCE. A SECOND PROCEDURE WAS PERFORMED ON UNKNOWN DATE BETWEEN (B)(6) AND (B)(6). THE SURGEON REPORTED THAT THE ABSCESS DEVELOPED ON THE TAB PORTION OF THE SUTURE. THE SUTURE WAS REMOVED AND IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT RECEIVED ANTIBIOTICS AND IS REPORTED AS NOT GETTING WORSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess; Not Applicable; Wound Dehiscence

  MAUDE report 8079183 ↗