STRATAFIX SXPP1B433Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705031246546), received between Feb 3, 2021 and May 14, 2026 — classified as 2 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT BARBED SUTURE SPITTING AT THE SUBCUTANEOUS LEVEL. NO SURGICAL DELAY AND NO PATIENT HARM WAS REPORTED. DEVICE IS NOT RETURNING AS IT WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172353 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. SUTURE WAS BEING HANDLED ROBOTICALLY IN NORMAL FASHION WITH SUTURE STRAND BROKE UNEXPECTEDLY. NO EXTRANEOUS FORCE WAS APPLIED. NORMAL ROBOTIC INSTRUMENTS WERE BEING USED. BREAKAGE OCCURRED TWICE INTRA-OP BUT SUTURING WAS BEGUN, SO NO PATIENT CONSEQUENCES WERE OBSERVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926443 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. SUTURE WAS BEING HANDLED ROBOTICALLY IN NORMAL FASHION WITH SUTURE STRAND BROKE UNEXPECTEDLY. NO EXTRANEOUS FORCE WAS APPLIED. NORMAL ROBOTIC INSTRUMENTS WERE BEING USED. BREAKAGE OCCURRED TWICE INTRA-OP BUT SUTURING WAS BEGUN, SO NO PATIENT CONSEQUENCES WERE OBSERVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926424 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN A HERNIA REPAIR PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING A ROBOTIC HERNIA REPAIR PROCEDURE, THERE ARE TWO SEPARATE OCCASIONS THAT THE SUTURES BROKE WHILE SUTURING. NO PATIENT HARM AND THEY ONLY GRAB ANOTHER SUTURE TO CONTINUE THE SURGERY. DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680076 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN A HERNIA REPAIR PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT DURING A ROBOTIC HERNIA REPAIR PROCEDURE, THERE ARE TWO SEPARATE OCCASIONS THAT THE SUTURES BROKE WHILE SUTURING. NO PATIENT HARM AND THEY ONLY GRAB ANOTHER SUTURE TO CONTINUE THE SURGERY. DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680075 ↗
• InjuryJan 6, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT THAT THEY UNDERWENT A LAPAROSCOPIC MYOMECTOMY NEEDED FOR HER MENORRHAGIA AND MULTI FIBROIDS IN HER UTERUS ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE BROKE AT THE 2/3 JUNCTION AND BECAME EMBEDDED IN HER UTERINE WALL. THE SURGEONS WERE UNABLE TO REMOVE THIS LAPAROSCOPICALLY, SO THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY. OTHER COLLEAGUES HAD TO BE CALLED IN TO THE THEATRE TO ASSIST, AND THE PATIENT WAS IN THEATRE FOR SEVERAL HOURS LONGER THAN PLANNED. THE BROKEN NEEDED WAS REMOVED. THE PATIENT WAS ADVISED THAT THE ENTIRE BATCH OF NEEDLES WAS SENT BACK BY THE HOSPITAL TO THE MANUFACTURER FOR INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21086181 ↗
• MalfunctionNov 6, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN ROBOTIC PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE NEEDLE POPPED OFF DURING USE. THERE WAS NO ADVERSE EVENT REPORTED. ADDITIONAL SUTURE WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623506 ↗
• MalfunctionOct 30, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THEY WERE USING 2-0 BARBED SUTURE, AND WERE CLOSING UP THE DEEPER LAYER, UNDER ZERO TENSION, HE WENT FOR A THROW AND THE SUTURE BROKE OFF THE NEEDLE FROM THE SWAGE. THE NEEDLE HAD TO BE FISHED OUT AND THEY OPENED ANOTHER DEVICE TO COMPLETE CASE. CAUSED SMALL DELAY IN PROCEDURE. NO PATIENT HARM. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570471 ↗
• MalfunctionAug 7, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON STATED THE SUTURE WAS DULL AND NEEDED A NEW SUTURE BECAUSE THE SUTURE TIP HAD BROKE OFF. THE SUTURE TIP DISCOVERED IN THE GRIPS OF THE NEEDLE DRIVER. THE SUTURE TIP EXAMINED BY SURGICAL TEAM AND WAS DETERMINED TO BE COMPLETE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927347 ↗
• MalfunctionApr 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC UTERINE MYOMECTOMY ON AN UNKNOWN DATE IN 2024 AND BARBED SUTURE WAS USED. THE PHYSICIAN'S ASSISTANT PUT THE SUTURE THROUGH A SIZE 8 ROBOT TROCAR AND THE NEEDLE FELL OFF THE SUTURE. IT WAS HARD TO TELL IF IT FELL OFF IN THE TROCAR DURING INSERTION AND THEN FELL INTO THE BODY CAVITY OR IF IT FELL OFF AFTER THE SUTURE WAS IN THE TROCAR. SURGEON WAS ABLE TO FIND THE NEEDLE AND REMOVED IT. SURGEON USED A NEW SUTURE TO FINISH THE CASE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061588 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT AS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A WOUND DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 18855932 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE THREAD DURING USE, TESTED ON FIVE PIECES OF DIFFERENT SEWING SLEEVES FROM THE SEWING PACKAGE WITH THE SAME RESULT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675623 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE THREAD DURING USE, TESTED ON FIVE PIECES OF DIFFERENT SEWING SLEEVES FROM THE SEWING PACKAGE WITH THE SAME RESULT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675622 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE THREAD DURING USE, TESTED ON FIVE PIECES OF DIFFERENT SEWING SLEEVES FROM THE SEWING PACKAGE WITH THE SAME RESULT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675620 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE THREAD DURING USE, TESTED ON FIVE PIECES OF DIFFERENT SEWING SLEEVES FROM THE SEWING PACKAGE WITH THE SAME RESULT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675618 ↗
• MalfunctionFeb 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AWAY FROM THE THREAD DURING USE, TESTED ON FIVE PIECES OF DIFFERENT SEWING SLEEVES FROM THE SEWING PACKAGE WITH THE SAME RESULT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675617 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE BROKE WHEN TRYING TO INSERT THROUGH THE TROCAR. THE SURGERY WAS DELAYED BY 1-2 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM AND NO ADVERSE PATIENT CONSEQUENCES. THE COORDINATOR OPINED THAT IT HASN'T HAPPENED ANY OTHER TIME AND SHE BELIEVES IT WAS THE TECHNICIAN'S TECHNIQUE WITH TRYING TO PLACE THROUGH A TROCAR THAT WAS TOO SMALL INSTEAD OF A TRUE PRODUCT MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756463 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE BROKE WHEN TRYING TO INSERT THROUGH THE TROCAR. THE SURGERY WAS DELAYED BY 1-2 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM AND NO ADVERSE PATIENT CONSEQUENCES. THE COORDINATOR OPINED THAT IT HASN'T HAPPENED ANY OTHER TIME AND SHE BELIEVES IT WAS THE TECHNICIAN'S TECHNIQUE WITH TRYING TO PLACE THROUGH A TROCAR THAT WAS TOO SMALL INSTEAD OF A TRUE PRODUCT MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756461 ↗
• MalfunctionDec 21, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING APART AND THE BARBS WOULD NOT CATCH. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022622 ↗
• MalfunctionDec 21, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING APART AND THE BARBS WOULD NOT CATCH. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. NO ADDITIONAL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022621 ↗
• MalfunctionDec 21, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING APART AND THE BARBS WOULD NOT CATCH. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. NO ADDITIONAL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022620 ↗
• MalfunctionDec 21, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING APART AND THE BARBS WOULD NOT CATCH. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. NO ADDITIONAL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022619 ↗
• MalfunctionDec 21, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT BREAKING APART AND THE BARBS WOULD NOT CATCH. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. NO ADDITIONAL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022618 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE ROBOTIC SURGERY, THE SURGEON GRABBED THE SUTURE WITH NEEDLE HOLDER. AFTER FIRST STITCH, THE SUTURE WAS BROKEN. IT HAPPENED TO THE NEXT 3-4 SUTURES IN THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13088782 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE ROBOTIC SURGERY, THE SURGEON GRABBED THE SUTURE WITH NEEDLE HOLDER. AFTER FIRST STITCH, THE SUTURE WAS BROKEN. IT HAPPENED TO THE NEXT 3-4 SUTURES IN THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13088668 ↗