STRATAFIX SXPP1A201Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10705031227705), received between Jul 23, 2018 and Sep 30, 2026 — classified as 14 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Break” (61 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 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949642 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50947336 ↗
• 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 50947320 ↗
• MalfunctionSep 24, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used. After the first stitch passes through Fasia, pull it all the way to secure the Fixation Loop, but the loop breaks and separates from the thread, making it unusable. There were no patient consequences reported. There were no surgical delays reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886576 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHILE SUTURING, THE FIXATION TAP WAS DETACHED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172785 ↗
• MalfunctionApr 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OBLIQUE LATERAL INTERBODY FUSION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, DURING AN OBLIQUE LATERAL INTERBODY FUSION, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING USE. THIS EVENT WAS FOUND BEFORE USE. THE PRODUCT WAS USED FOR CLOSED WOUND. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049048 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAP WAS DETACHED WHILE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847541 ↗
• MalfunctionApr 6, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2026 BARBED SUTURE WAS USED. DURING SURGERY, IT WAS FOUND THAT THE SUTURE HAD FRAYED IMMEDIATELY AFTER THE PRODUCT WAS USED. USE WAS STOPPED. THE PRODUCT WAS USED ON THE FASCIA. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794005 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE NEEDLE AND SUTURE WAS DETACH, WHILE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160259 ↗
• MalfunctionJan 6, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE AND NEEDLE WAS DETACHED WHILE SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973729 ↗
• MalfunctionSep 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE THREAD CAME LOOSE FROM THE NEEDLE AND WAS REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100457 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THIS SUTURE HAD BEEN USED THE SAME AS BEFORE, BUT THE SUTURE WAS BROKEN DURING STITCHING EVEN THOUGH THE TENSION WAS NOT APPLIED MUCH. IT WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915838 ↗
• MalfunctionAug 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, THE DATE OF MANUFACTURE IN NF OR PHYSICAL OF THE PRODUCT IS NOT SPECIFIED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815703 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS USED AS USUAL DURING THE SURGERY, BUT THE SUTURE WAS BROKEN THOUGH NO EXTRA TENSION WAS APPLIED. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. 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 22145591 ↗
• MalfunctionMay 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976294 ↗
• MalfunctionMay 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976291 ↗
• MalfunctionMay 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976290 ↗
• MalfunctionMay 7, 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, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976150 ↗
• MalfunctionMay 7, 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, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976146 ↗
• MalfunctionMay 7, 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, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976145 ↗
• MalfunctionMay 7, 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, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976099 ↗
• MalfunctionMay 7, 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, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976098 ↗
• MalfunctionMay 7, 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, ACCORDING TO THE DOCTOR'S REPORT, THE THREAD IS UNCOILED FROM THE NEEDLE. HE HAS BEEN USING THIS THREAD FOR ABOUT 3 YEARS AND THIS PROBLEM HAS BEEN OCCURRING SINCE (B)(6) 2025. I REQUESTED TO STORE THE NEXT WIRE FOR ANALYSIS. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976091 ↗
• MalfunctionApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE WAS DETACHED DURING OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738226 ↗
• MalfunctionNov 19, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND BARBED SUTURE WAS USED. NEEDLE AND SUTURE SEPARATE(WITHOUT LOT). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728943 ↗