STRATAFIX SXMP1B102Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031236615), received between Mar 14, 2019 and Sep 30, 2026 — classified as 17 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and a barbed suture was used. It was stated by the ortho surgeon that they using the barbed suture in (b)(6) 2026. Post-op, the patient experienced an infection. The surgeon started to notice an uptick in infection recently and can not pin point the cause, but want to go back to using a different suture to see if it goes away. The surgeon also started using Slyke Dressing during this time. Additional information was requested.

  Patient problems: Unspecified Infection

  MAUDE report 50947345 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50947330 ↗
• MalfunctionApr 29, 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 SUTURE BROKE WHEN THE DOCTOR TIGHTENED IT AFTER TWO STITCHES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035220 ↗
• MalfunctionFeb 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. 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 24475753 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHILE SURGEON SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475434 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND BARBED SUTURE WAS USED. PATIENT SKIN SHOWED SIGNS OF INFECTION & ALLERGY TO THE SUTURE AFTER 10 DAYS OF FOLLOW-UP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 23846654 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND BARBED SUTURE WAS USED. PATIENT SKIN SHOWED SIGNS OF INFECTION & ALLERGY TO THE SUTURE AFTER 10 DAYS OF FOLLOW-UP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 23846653 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT AN EYE SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE PATIENT STATED THEY WERE ALLERGIC TO SOMETHING, STITCH IN EYE HAVING ISSUES AND HAVING ALLERGY TESTING. ON (B)(6), THE PATIENT HAD SWELLING AND COULD NOT PUT WEIGHT ON IT. THE PATIENT STATED THEY MAY BE ALLERGIC TO NICKEL. THE EYE SURGEON STATED THE PATIENT HAD A REACTION AND TOOK CARE OF IT WITH ANTIBIOTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 23309361 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY UNDERWENT A KNEE SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE PATIENT STATED THEY WERE ALLERGIC TO SOMETHING AND HAVING ALLERGY TESTING. ON (B)(6), THE PATIENT HAD SWELLING AND COULD NOT PUT WEIGHT ON IT. THE PATIENT STATED THEY MAY BE ALLERGIC TO NICKEL. THE SURGEON STATED THE PATIENT HAD A REACTION AND TOOK CARE OF IT WITH ANTIBIOTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Impaired Healing; Swelling/ Edema

  MAUDE report 23309357 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22972740 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22970934 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22969717 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. SUTURE STILL THERE 4-6 WEEKS. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968762 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968671 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968463 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968390 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED TO CLOSE THE SKIN. THREE WEEKS LATER. THE SUTURE WAS SPIT OUT OF THE SKIN AND 3-4 CM OF THE BARBED SUTURE WAS STICKING OUT. THE WOUND DEVELOPED AN INFECTION. THE WOUND COMPLICATION WAS ADDRESSED WITH ADDITIONAL SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 22654449 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE NEEDLE EASILY DESWAGED DURING ROUTINE USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375657 ↗
• MalfunctionJul 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE NEEDLE EASILY DESWAGED DURING ROUTINE USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375653 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP ON THE SUTURE CAME APART ON THE INITIAL PLACEMENT THROW, AND THE SUTURE PULLED OUT THROUGH THE TISSUE. THE SURGEON WAS UNABLE TO SECURE THE INITIAL THROW. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734438 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP ON THE SUTURE CAME APART ON THE INITIAL PLACEMENT THROW, AND THE SUTURE PULLED OUT THROUGH THE TISSUE. THE SURGEON WAS UNABLE TO SECURE THE INITIAL THROW. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734397 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP ON THE SUTURE CAME APART ON THE INITIAL PLACEMENT THROW, AND THE SUTURE PULLED OUT THROUGH THE TISSUE. THE SURGEON WAS UNABLE TO SECURE THE INITIAL THROW. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734176 ↗
• MalfunctionMar 19, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE CLOSING THE WOUND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18934928 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ELBOW SURGERY FOR AN OLECRANON FRACTURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SURGEON NOTICED ON (B)(6) 2023 THAT THE WOUND HAD SOME FLUIDS COMING OUT. HE ASSUMES THAT IT MIGHT BE A REACTION TO THE BARBED SUTURE OR THE METAL IMPLANTS HE USED. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6) 2023 TO REMOVE THE IMPLANTS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 18135836 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL TKR ON (B)(4) 2023 AND BARBED SUTURE WAS USED ON THE SKIN. WOUND BREAKDOWN WAS NOTED 4/52 POST OP ON ONE KNEE ONLY. IT STARTED WITH A SCAB AND PATIENT WAS ATTENDING POOL TWICE WEEKLY. PATIENT HAD ADDITIONAL VISITS FOR DRESSING CHANGE AND ANTIBIOTIC TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17025377 ↗