STRATAFIX SXPP1A406Recalls & reported problems
Ethicon, LLC · Violet Antibacterial Polydioxanone, Knotless Tissue Control Device · Class 2 · Implant
Quick summary
This Ethicon Stratafix knotless suture, an absorbable surgical thread, has 338 reports, 12 of them injuries and no deaths. The reports mostly describe the suture breaking or separating during stitching, forcing surgeons to switch to another one, and several say no patient consequences were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 339
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 339 adverse event reports that list this exact device (DI 10705031227675), received between Dec 8, 2017 and Sep 16, 2026 — classified as 12 injuries, 327 malfunctions.
The most frequently reported specific device problem is “Break” (222 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.
Reports received per month
Most reported problems
Device problems
- Break222
- Material Separation73
- Material Integrity Problem32
- Adverse Event Without Identified Device or Use Problem5
- Delivered as Unsterile Product4
- Appropriate Device Problem Term/Code Not Available3
- Material Twisted/Bent2
- Packaging Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions265
- No Consequences Or Impact To Patient53
- Insufficient Information7
- Foreign Body In Patient4
- Hemorrhage/Blood Loss/Bleeding3
- Inflammation3
- Not Applicable3
- Wound Dehiscence3
Recent adverse event reports
The 25 most recent of 339 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Break
It was reported that a patient underwent an Orthopedic procedure on an unknown date and suture was used. A total of 3 products occurred suture breakage issue when the surgeon attempted to sew the tissue. Changed 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 50788929 ↗MalfunctionSep 16, 2026Break
It was reported that a patient underwent an Orthopedic procedure on an unknown date and suture was used. A total of 3 products occurred suture breakage issue when the surgeon attempted to sew the tissue. Changed 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 50788903 ↗MalfunctionSep 16, 2026Break
It was reported that a patient underwent an Orthopedic procedure on an unknown date and suture was used. A total of 3 products occurred suture breakage issue when the surgeon attempted to sew the tissue. Changed 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 50788824 ↗MalfunctionAug 27, 2026Break
It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and suture was used. It was reported that the suture broke when sewing in an unknown surgery. Changed another one to complete the surgery. There were no patient consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50478521 ↗MalfunctionAug 24, 2026Break
It was reported that a patient underwent a fasciorrhaphy procedure on (b)(6) 2026 and barbed suture was used. During the procedure, the suture was broken during a fasciorrhaphy. The same product was taken out as a replacement, and the suturing was completed. It was not a control release needle. When we send the sample to you, we will let you know its return date and tracking number. 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 50407525 ↗MalfunctionAug 17, 2026Break
It was reported that a patient underwent an unknown procedure on (b)(6)2026 and suture was used. During the use of suture by doctor, the suture was pulled and broke, requiring replacement, which increased the surgical time and patient burden. No adverse patient consequences were reported. Additional information was requested
Patient problems: Insufficient Information
MAUDE report 50274487 ↗MalfunctionJun 26, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633979 ↗MalfunctionJun 26, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. T WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25633865 ↗MalfunctionMay 29, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25337804 ↗MalfunctionMay 27, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25299411 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED 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 25021222 ↗MalfunctionApr 9, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE CLOSURE OF THE ABDOMEN AFTER SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829941 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780797 ↗MalfunctionApr 3, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776917 ↗MalfunctionApr 3, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776856 ↗MalfunctionApr 3, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24776789 ↗MalfunctionApr 1, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING THE SURGICAL PROCEDURE, THE NEEDLE BROKE IN THE ABDOMINAL CAVITY. THE BROKEN NEEDLE WAS IMMEDIATELY REMOVED COMPLETELY FROM THE ABDOMINAL CAVITY AND REPLACED WITH A NEW SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24757133 ↗MalfunctionFeb 23, 2026Break
IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026, AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24415267 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24273055 ↗MalfunctionJan 28, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE ACTUAL SAMPLE CAN'T BE RETURNED, 1 ACTUAL SAMPLE WERE DISCARD, BUT 5 STERILE SAMPLES FROM SAME BATCH WILL BE RETURNED FOR ANALYSIS. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24201270 ↗MalfunctionJan 8, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC EXAMINATION+HYSTEROSCOPY+HYSTEROSCOPIC TUBAL PATENCY SURGERY+HYSTEROSCOPIC HYSTEROSCOPIC BIOPSY SURGERY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EXAMINATION DUE TO "FOUND FALLOPIAN TUBE DISEASE FOR MORE THAN 1 YEAR". THREE DAYS LATER, THE SURGERY WAS PERFORMED. DURING THE SURGERY, THE NEEDLE WAS BROKEN WHEN THE SUTURE WAS USED FOR SUTURING, WHICH PROLONGED THE SURGERY TIME OF THE PATIENT. THE NURSE IMMEDIATELY REPLACED A NEW SUTURE FOR USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24014533 ↗MalfunctionDec 24, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.3
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888518 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE CHIEF SURGEON USED A CURVED FORCEPS TO PULL THE SUTURE AFTER SUTURING, THE SUTURE BROKE. THE BROKEN SUTURE WAS RECONNECTED TO COMPLETE THE SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851945 ↗MalfunctionDec 18, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839043 ↗MalfunctionDec 9, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. T WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756190 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
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- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
- PDS Z494GEthicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 recall159 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.