STRATAFIX SXPP2B408Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031464810), received between Nov 6, 2023 and Apr 20, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PRODUCT BROKE DURING THE OPERATION. THE BARBED SUTURE WAS BEING USED IN CLOSURE. IT¿S UNKNOWN WHAT LAYER THE SUTURE WAS BEING USED IN. THE PROCEDURE WAS DELAYED 25 MINUTES DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924870 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PRODUCT BROKE DURING THE OPERATION. THE BARBED SUTURE WAS BEING USED IN CLOSURE. IT¿S UNKNOWN WHAT LAYER THE SUTURE WAS BEING USED IN. THE PROCEDURE WAS DELAYED 25 MINUTES DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924846 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PRODUCT BROKE DURING THE OPERATION. THE BARBED SUTURE WAS BEING USED IN CLOSURE. IT¿S UNKNOWN WHAT LAYER THE SUTURE WAS BEING USED IN. THE PROCEDURE WAS DELAYED 25 MINUTES DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924810 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC JOINT PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PRODUCT BROKE DURING THE OPERATION. THE BARBED SUTURE WAS BEING USED IN CLOSURE. IT¿S UNKNOWN WHAT LAYER THE SUTURE WAS BEING USED IN. THE PROCEDURE WAS DELAYED 25 MINUTES DUE TO THE REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924694 ↗
• MalfunctionNov 22, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING A CASE THAT WHEN THEY WERE ATTEMPTING TO TIGHTEN THE SUTURE IT WOULD POP OF FROM THE NEEDLE. SURGEON OPTED TO USE A BASIC SUTURE TO COMPLETE THE CASE WITHOUT ANY PATIENT HARM. NO NEEDLES FELL INTO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760635 ↗
• MalfunctionNov 22, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING A CASE THAT WHEN THEY WERE ATTEMPTING TO TIGHTEN THE SUTURE IT WOULD POP OFF FROM THE NEEDLE. SURGEON OPTED TO USE A BASIC SUTURE TO COMPLETE THE CASE WITHOUT ANY PATIENT HARM. NO NEEDLES FELL INTO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759331 ↗
• MalfunctionNov 22, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. DURING A CASE THAT WHEN THEY WERE ATTEMPTING TO TIGHTEN THE SUTURE IT WOULD POP OFF FROM THE NEEDLE. SURGEON OPTED TO USE A BASIC SUTURE TO COMPLETE THE CASE WITHOUT ANY PATIENT HARM. NO NEEDLES FELL INTO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759319 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074740 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074734 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074731 ↗