STRATAFIX SXPP1A434Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031245068), received between Jan 24, 2024 and Apr 29, 2025 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE SNAPPED WHILE APPROXIMATING TISSUE. THERE WERE NO INCORRECT SURGICAL TECHNIQUES OBSERVED, AND AFTERWARDS SIMILAR USE OF COMPETITOR PRODUCT DID NOT RESULT IN ANY BROKEN STRANDS. THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930298 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE SNAPPED WHILE APPROXIMATING TISSUE. THERE WERE NO INCORRECT SURGICAL TECHNIQUES OBSERVED, AND AFTERWARDS SIMILAR USE OF COMPETITOR PRODUCT DID NOT RESULT IN ANY BROKEN STRANDS. THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930277 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE SNAPPED WHILE APPROXIMATING TISSUE. THERE WERE NO INCORRECT SURGICAL TECHNIQUES OBSERVED, AND AFTERWARDS SIMILAR USE OF COMPETITOR PRODUCT DID NOT RESULT IN ANY BROKEN STRANDS. THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930255 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE OPERATING ROOM TEACHER REPORTED THAT DURING THE SURGERY ON THE MORNING , THE DOCTOR ON THE OPERATING TABLE STARTED SUTURING WITH SUTURE. HOWEVER, THE SUTURE HAD SPLIT AND COULD NOT BE USED, AND TWO NEEDLES OF THE SAME MODEL WERE USED CONSECUTIVELY, RESULTING IN SAMPLE PROBLEMS AND DELAYING THE SURGICAL PROCESS AND OPERATION TIME. CHANGED ANOTHER ONE TO COMPLETE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631259 ↗
• MalfunctionNov 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE OPERATING ROOM TEACHER REPORTED THAT DURING THE SURGERY ON THE MORNING. THE DOCTOR ON THE OPERATING TABLE STARTED SUTURING WITH SUTURE. HOWEVER, THE SUTURE HAD SPLIT AND COULD NOT BE USED, AND TWO NEEDLES OF THE SAME MODEL WERE USED CONSECUTIVELY, RESULTING IN SAMPLE PROBLEMS AND DELAYING THE SURGICAL PROCESS AND OPERATION TIME. CHANGED ANOTHER ONE TO COMPLETE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631207 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577072 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18577071 ↗