STRATAFIX SXPP1A404Recalls & reported problems

Summary

The FDA's MAUDE database contains 319 adverse event reports that list this exact device (DI 10705031227699), received between Dec 26, 2017 and Sep 14, 2026 — classified as 1 death, 51 injuries, 267 malfunctions.

The most frequently reported specific device problem is “Break” (212 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 319 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757647 ↗
• MalfunctionJun 16, 2026Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY AND BARBED SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN TWO STITCHES WERE USED DURING THE SURGERY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521440 ↗
• MalfunctionApr 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25003770 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE WHEN SEWING IN SURGERY . CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933221 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AV FISTULA PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DOCTOR REPORTED THAT SUTURE GOT BROKE. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926248 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AV FISTULA PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DOCTOR REPORTED THAT SUTURE GOT BROKE. THERE WAS A SURGICAL DELAY OF A COUPLE OF MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926246 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. AT 13:30, THE PATIENT UNDERWENT SURGERY. DURING THE SURGERY, THE MYOMA WAS COMPLETELY STRIPPED ALONG THE CAPSULE. AFTER CHECKING THAT THERE WAS NO BLEEDING, THE BASAL PART OF THE UTERINE WOUND AND THE SEROMUSCULAR LAYER WERE SUTURED TWICE CONTINUOUSLY WITH SUTURE. DURING THE SUTURE PROCESS, THE SUTURE WAS SCATTERED AND SPLIT, WHICH AFFECTED THE SURGICAL USE. THEN THE SUTURE WAS REPLACED, AND IT WAS NORMAL TO SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926156 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911061 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910957 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON AN UNKNOWN DATE IN (B)(6) 2025 AND BARBED SUTURE WAS USED TO CLOSE THE FASCIA. RECENTLY, A WOUND DEHISCENCE OCCURRED. GIVEN THE PASSAGE OF TIME AND THE NATURAL DEGRADATION OF THE SUTURE MATERIAL, THIS INCIDENT DOES NOT CONSTITUTE A PRODUCT DEFECT INHERENT TO THE SUTURE ITSELF. HOWEVER, THE ATTENDING PHYSICIAN NOTED THAT THIS TYPE OF FAILURE¿SPECIFICALLY INVOLVING THE SUTURE KNOT¿HAD NOT BEEN OBSERVED IN PREVIOUS CASES. THE PHYSICIAN HYPOTHESIZED THAT THE DEHISCENCE MAY HAVE BEEN CAUSED BY ISCHEMIA RESULTING FROM THE CONTINUOUS SUTURING TECHNIQUE AND SUGGESTED THAT THIS SYSTEM MIGHT BE UNSUITABLE FOR WOUNDS IN PATIENTS WITH COMPROMISED CONDITIONS, SUCH AS THOSE UNDERGOING PANCREATICODUODENECTOMY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Ischemia; Wound Dehiscence

  MAUDE report 24774904 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY ON AN UNKNOWN DATE IN (B)(6) 2025 AND BARBED SUTURE WAS USED TO CLOSE THE FASCIA. RECENTLY, A WOUND DEHISCENCE OCCURRED. GIVEN THE PASSAGE OF TIME AND THE NATURAL DEGRADATION OF THE SUTURE MATERIAL, THIS INCIDENT DOES NOT CONSTITUTE A PRODUCT DEFECT INHERENT TO THE SUTURE ITSELF. HOWEVER, THE ATTENDING PHYSICIAN NOTED THAT THIS TYPE OF FAILURE¿SPECIFICALLY INVOLVING THE SUTURE KNOT¿HAD NOT BEEN OBSERVED IN PREVIOUS CASES. THE PHYSICIAN HYPOTHESIZED THAT THE DEHISCENCE MAY HAVE BEEN CAUSED BY ISCHEMIA RESULTING FROM THE CONTINUOUS SUTURING TECHNIQUE AND SUGGESTED THAT THIS SYSTEM MIGHT BE UNSUITABLE FOR WOUNDS IN PATIENTS WITH COMPROMISED CONDITIONS, SUCH AS THOSE UNDERGOING PANCREATICODUODENECTOMY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Ischemia; Wound Dehiscence

  MAUDE report 24774902 ↗
• InjuryJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT HAD A BMI OF OVER 30. THE PRODUCT WAS USED WITHOUT ANY ISSUES DURING THE SURGERY, AND THE POSTOPERATIVE COURSE WAS UNEVENTFUL. THE PATIENT WAS DISCHARGED AS IT IS. ONE MONTH AFTER DISCHARGE, THE PATIENT FELL AND SUSTAINED A PATELLAR DISLOCATION. X-RAY AND CT IMAGING CONFIRMED BREAKAGE OF THE SUTURE. REOPERATION WAS PERFORMED FOR RE-SUTURING. THE DOCTOR SAID THAT THE POSSIBILITY OF A DEFECT IN THE SUTURE ITSELF IS LOW. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Joint Dislocation

  MAUDE report 24069970 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN COLECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED TO CLOSE THE FASCIA. ONE WEEK LATER, THE WOUND BECAME INFECTED, AND THE FASCIAL TISSUE RUPTURED AND DEHISCED. THE SUTURE ITSELF WAS NOT BROKEN. BECAUSE THE SURGERY INVOLVED CONTAMINATION DUE TO GASTROINTESTINAL PERFORATION, THE DOCTOR DOES NOT BELIEVE THE SUTURE WAS NECESSARILY THE CAUSE. HOWEVER, SINCE THE TECHNIQUE HAD RECENTLY BEEN CHANGED FROM INTERRUPTED SUTURES, THE DOCTOR WAS CONCERNED. REOPERATION WAS PERFORMED AS TREATMENT. THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 24064298 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN PANCREATICODUODENECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. A VERTICAL LINEAR INCISION WAS SUTURED FROM BOTH SIDES USING TWO NEEDLE-SUTURES. ON DAY 4 AFTER THE SURGERY, THE TISSUE DEHISCENCE OCCURRED AROUND THE UMBILICAL AREA AT THE POINT WHERE THE TWO SUTURES CROSSED. THE SUTURES THEMSELVES WERE NOT BROKEN. THE HOSPITAL WONDERED WHETHER THERE MIGHT BE ANY ISSUE SO FAR RELATED TO USE BY INTERRUPTED BARBED SUTURES. THE HOSPITAL WAS EXPLAINED THAT EXCESSIVE TIGHTENING OF THE SUTURE OR OVERLAP OF TWO SUTURES DUE TO BACKSTITCHING COULD CAUSE ISCHEMIA. THE PRODUCT WAS USED ON THE FASCIA. REOPERATION WAS PERFORMED AND WOUND CLOSURE WAS DONE AFTER 4 DAYS. THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24064297 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN PANCREATICODUODENECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. A VERTICAL LINEAR INCISION WAS SUTURED FROM BOTH SIDES USING TWO NEEDLE-SUTURES. ON DAY 4 AFTER THE SURGERY, THE TISSUE DEHISCENCE OCCURRED AROUND THE UMBILICAL AREA AT THE POINT WHERE THE TWO SUTURES CROSSED. THE SUTURES THEMSELVES WERE NOT BROKEN. THE HOSPITAL WONDERED WHETHER THERE MIGHT BE ANY ISSUE SO FAR RELATED TO USE BY INTERRUPTED BARBED SUTURES. THE HOSPITAL WAS EXPLAINED THAT EXCESSIVE TIGHTENING OF THE SUTURE OR OVERLAP OF TWO SUTURES DUE TO BACKSTITCHING COULD CAUSE ISCHEMIA. THE PRODUCT WAS USED ON THE FASCIA. REOPERATION WAS PERFORMED AND WOUND CLOSURE WAS DONE AFTER 4 DAYS. THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24064296 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE RN WHO REPORTED THAT THE NEEDLE POPPED OFF THE STRATAFIX IN MULTIPLE SURGERIES. IT IS BELIEVED TO HAVE ALL BEEN FROM THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES. A STERILE SUTURE FROM THE SAME LOT NUMBER WILL BE RETURNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836917 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE RN WHO REPORTED THAT THE NEEDLE POPPED OFF THE STRATAFIX IN MULTIPLE SURGERIES. IT IS BELIEVED TO HAVE ALL BEEN FROM THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES. A STERILE SUTURE FROM THE SAME LOT NUMBER WILL BE RETURNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836914 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE RN WHO REPORTED THAT THE NEEDLE POPPED OFF THE STRATAFIX IN MULTIPLE SURGERIES. IT IS BELIEVED TO HAVE ALL BEEN FROM THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES. A STERILE SUTURE FROM THE SAME LOT NUMBER WILL BE RETURNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836872 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA PROCEDURE (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE RN WHO REPORTED THAT THE NEEDLE POPPED OFF THE STRATAFIX IN MULTIPLE SURGERIES. IT IS BELIEVED TO HAVE ALL BEEN FROM THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES. A STERILE SUTURE FROM THE SAME LOT NUMBER WILL BE RETURNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836871 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE RN WHO REPORTED THAT THE NEEDLE POPPED OFF THE STRATAFIX IN MULTIPLE SURGERIES. IT IS BELIEVED TO HAVE ALL BEEN FROM THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES. A STERILE SUTURE FROM THE SAME LOT NUMBER WILL BE RETURNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836868 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE RN WHO REPORTED THAT THE NEEDLE POPPED OFF THE STRATAFIX IN MULTIPLE SURGERIES. IT IS BELIEVED TO HAVE ALL BEEN FROM THE SAME LOT. THERE WERE NO PATIENT CONSEQUENCES. A STERILE SUTURE FROM THE SAME LOT NUMBER WILL BE RETURNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836865 ↗
• MalfunctionOct 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE NEEDLE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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 23393777 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA SURGERY IN 2025 AND BARBED SUTURE WAS USED. POST OP SUTURE BREAKAGE IN TKA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096061 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WAS USING THE SUTURE, AND THE NEEDLE BROKE. THEY GOT ANOTHER SUTURE, BUT IT BROKE AGAIN. THERE WERE NO PATIENT ADVERSE EVENT. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075824 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WAS USING THE SUTURE, AND THE NEEDLE BROKE. THEY GOT ANOTHER SUTURE, BUT IT BROKE AGAIN. THERE WERE NO PATIENT ADVERSE EVENT. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075671 ↗