STRATAFIX SXMP1B101Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10705031236776), received between Jul 10, 2018 and Sep 29, 2026 — classified as 10 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931540 ↗
• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223129 ↗
• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222248 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. WHILE PERFORMING SUTURING ON PATIENT, THE SUTURE BROKE AND WAS IMMEDIATELY STOPPED AND REPLACED WITH A NEW SUTURE. THE SUTURING WORK WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250385 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IN THE OPERATING ROOM, DOCTOR USED SUTURE TO SUTURE THE PATIENT AND FOUND THAT THE END OF THE SUTURE WAS BROKEN AND UNUSABLE. THE SUTURE WAS IMMEDIATELY REPLACED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185628 ↗
• MalfunctionSep 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121607 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND A BARBED SUTURE WAS USED. DURING THE INTRAOPERATIVE SUTURING PROCESS, THE SUTURE BROKE. THE SURGEON IMMEDIATELY STOPPED USING THE SUTURE AND REPLACE WITH A NEW SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED, ADDITIONAL INFORMATION WAS REQUESTED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020374 ↗
• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE LOOP FAILED TO FUNCTION. IT WAS REPORTED THAT THE LOOP WAS LOOSE WHEN IT WAS USED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381286 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITHIN THE LAST 18 MONTHS AND A BARBED SUTURE WAS USED. POST-OP, THE PRODUCT WAS SPITTING. THE PATIENT RETURNED WITH PROBLEMS. THE DRESSING WAS CHANGED AND THE PATIENT CONTINUED TO RETURN. THE DOCTOR IS NOT SURE WHAT THE ISSUE WAS. IT HAS BEEN NARROWED DOWN TO ISSUES WITH THE BARBED SUTURE. THE SKIN SPITTING OUT, THE BAR IN THE WOUND WHERE THE REACTION IS OCCURRING. THE DOCTOR TRIED RUBBING IT, AND TEN DAYS TO TWO WEEKS LATER, IT DISSOLVED. WITHIN TWO TO THREE WEEKS, THE PATIENT WAS UNCOMFORTABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Local Reaction; Pocket Erosion

  MAUDE report 21323606 ↗
• MalfunctionNov 13, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE SUTURE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE, THE SUTURE BEGAN WITH THE DEGRADATION PROCESS; THIS CONDITION LIKELY CAUSED THE SUTURE TO BREAK. THE TIME OF EXPOSURE OF THE SUTURE TO THE ENVIRONMENT COULD NOT BE DETERMINED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675689 ↗
• MalfunctionOct 25, 2024Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY . CHANGED ANOTHER ONE TO CONTINUE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536071 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A PACEMAKER PROCEDURE ON AN UNKNOWN DATE IN 2024 AND BARBED SUTURE WAS USED. SURGEON IMPLANTED A DEVICE AND THREE WEEKS LATER THE PATIENT HAD TO BE READMITTED DUE TO SUPERFICIAL DEHISCENCE AND INFECTION. NEW IMPLANT PUT IN AFTER INFECTION WAS CLEARED. NEW IMPLANT PUT IN (B)(6), ORIGINAL CASE A MONTH PRIOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 19983282 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2024; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18964169 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963748 ↗
• MalfunctionMar 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP SURGERY ON (B)(6)2024, AND BARBED SUTURE WAS USED. THE NEEDLES CAME AWAY FROM TWO SUTURES DURING SURGERY. THEY WERE REPLACED WITH A LIKE PRODUCT. THERE WAS NO REPORTED SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832714 ↗
• MalfunctionMar 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2024, AND BARBED SUTURE WAS USED. THE NEEDLES CAME AWAY FROM TWO SUTURES DURING SURGERY. THEY WERE REPLACED WITH A LIKE PRODUCT. THERE WAS NO REPORTED SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832711 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN CLAVICLE FRACTURE REPAIR ON (B)(6) 2023 AND A BARBED SUTURE WAS USED ON THE SKIN AND SUBCUTANEOUS TISSUE. POST-OP, ON (B)(6) 2023, THE PATIENT RETURNED TO THE HOSPITAL FOR REEXAMINATION, AND COMPLAINED OF PUS, REDNESS AND HEAT IN THE WOUND. THE DOCTOR FOUND WOUND INFECTION AFTER EXAMINATION. THE DOCTOR PERFORMED DEBRIDEMENT, REMOVED THE ORIGINAL SUTURE AT THE WOUND AND REPLACED IT WITH A NEW SUTURE TO SEW THE WOUND. THEN THE PATIENT'S SYMPTOMS GRADUALLY IMPROVED. THE REMOVED SUTURE WAS PLACED IN PETRI DISH BY HOSPITAL, AND STAPHYLOCOCCUS AUREUS WAS CULTURED. NO SUBSEQUENT ADVERSE EVENTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Purulent Discharge; Unspecified Infection

  MAUDE report 17861298 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HUMERUS FRACTURE REPAIR ON (B)(6) 2023 AND A BARBED SUTURE WAS USED ON THE SKIN AND SUBCUTANEOUS TISSUE. POST-OP, ON (B)(6) 2023, THE PATIENT RETURNED TO THE HOSPITAL FOR REEXAMINATION, AND COMPLAINED OF WOUND REDNESS AND HEAT WITH PUS DISCHARGE. THE DOCTOR FOUND WOUND INFECTION DURING EXAMINATION. THE DOCTOR PERFORMED DEBRIDEMENT, REMOVED THE ORIGINAL SUTURE AT THE WOUND AND REPLACED IT WITH A NEW SUTURE TO SEW THE WOUND. THEN THE PATIENT'S SYMPTOMS WERE GRADUALLY IMPROVED. THE REMOVED SUTURE WAS PLACED IN PETRI DISH BY HOSPITAL, AND STAPHYLOCOCCUS AUREUS WAS CULTURED. NO SUBSEQUENT ADVERSE EVENTS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Purulent Discharge; Unspecified Infection

  MAUDE report 17860997 ↗
• InjurySep 9, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT RETURNED TO THE CLINIC WITH A PARTIALLY OPEN INCISION WITHIN THE PAST FEW MONTHS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15390299 ↗
• InjurySep 9, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT RETURNED TO THE CLINIC WITH A PARTIALLY OPEN INCISION WITHIN THE PAST FEW MONTHS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15390287 ↗
• InjurySep 7, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE INCISION WAS PARTIALLY OPEN WHEN PATIENT RETURNED TO CLINIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15374360 ↗
• InjuryJul 29, 2022Adverse 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) 2022 AND A BARBED SUTURE WAS USED FOR SKIN CLOSURE. THE PATIENT WENT IN FOR THEIR POST-OP 6 WEEK CHECK UP AND THE SUTURE HAD MIGRATED. THE SUTURE HAD MIGRATED TO THE VULVA. THE PATIENT HAD PAIN. IT WAS REPORTED THAT A FURTHER PROCEDURE IS NOT BEING PERFORMED AS THE SUTURES WILL ABSORB. IT WAS STATED THAT NO CHANGE HAD BEEN MADE TO TECHNIQUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Pocket Erosion

  MAUDE report 15128674 ↗
• InjuryJul 29, 2022Adverse 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) 2022 AND A BARBED SUTURE WAS USED FOR SKIN CLOSURE. THE PATIENT WENT IN FOR THEIR POST-OP 6 WEEK CHECK UP AND THE SUTURE HAD MIGRATED. THE SUTURE WAS 5 CM LATERALLY FROM THE PFANNENSTIEL INCISION TOWARDS THE UMBILICUS. THE PATIENT HAD PAIN. IT WAS REPORTED THAT A FURTHER PROCEDURE IS NOT BEING PERFORMED AS THE SUTURES WILL ABSORB. IT WAS STATED THAT NO CHANGE HAD BEEN MADE TO TECHNIQUE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Pocket Erosion

  MAUDE report 15128671 ↗
• MalfunctionMay 3, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBS ARE TOO SMALL AND DO NOT GRAB. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269616 ↗
• MalfunctionApr 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, AT THE END OF THE INCISION THE SUTURE BROKE WHILE PULLING THROUGH THE TOP LAYER OF SKIN. ANOTHER DEVICE WAS NOT NEEDED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088863 ↗