STRATAFIX SXMP1B103Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 10705031236622), received between Aug 13, 2018 and Apr 8, 2026 — classified as 30 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (47 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 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. SUTURE BROKE OFF DURING CLOSURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816233 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. SIMPLE STRETCHING OF STRATAFIX LED TO CUTOFF OF SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959174 ↗
• MalfunctionOct 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGAL NERVE STIMULATOR PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A REVISION OF VAGAL NERVE STIMULATOR PROCEDURE, A RUSTY NEEDLE WAS RETRIEVED FROM THE STERILE FIELD. IT IS UNKNOWN IF THERE WERE ANY PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289736 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND DISRUPTION AND SKIN REACTION AND FELT IT JUST IN THE INCISION. THE PATIENT WENT BACK FOR I&D WASHOUT. SURGEON SENT CULTURES. THE RESULTS ARE NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Seroma; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 22907105 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND OPENING AND REQUIRED TO GO BACK FOR WOUND CLOSURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22867240 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND OPENING AND REQUIRED TO GO BACK FOR WOUND CLOSURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22862847 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND OPENING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22861881 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND OPENING AND REQUIRED TO GO BACK FOR WOUND CLOSURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22861880 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED WOUND OPENING AND REQUIRED TO GO BACK FOR WOUND CLOSURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22861879 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY PA-C SURGEON THE SUTURE WAS BREAKING SEVERAL TIMES OVER PREVIOUS CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE RETURN STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738600 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY PA-C SURGEON THE SUTURE WAS BREAKING SEVERAL TIMES OVER PREVIOUS CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE RETURN STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738583 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY PA-C SURGEON THE SUTURE WAS BREAKING SEVERAL TIMES OVER PREVIOUS CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE RETURN STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738550 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY PA-C SURGEON THE SUTURE WAS BREAKING SEVERAL TIMES OVER PREVIOUS CASES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE RETURN STATUS IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738539 ↗
• MalfunctionJul 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SALES REP PER ACCOUNT THAT NEEDLE POPPED OFF AFTER FIRST THROW. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535222 ↗
• MalfunctionJul 11, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING CLOSURE OF SURGICAL SITE, IT WAS IDENTIFIED THAT THE END OF THE SUTURE NEEDLE WAS MISSING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478745 ↗
• MalfunctionJun 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE ACCOUNT CONTACT THAT, ON TWO SEPARATE OCCASIONS THE NEEDLE WOULD POP OFF TOWARDS THE END OF SUTURING. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323135 ↗
• MalfunctionMar 20, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP WENT UP, THEY OPENED A NEW SUTURE AND THE SAME THING HAPPENED AGAIN. 3 SUTURES WHERE THE SAME THING HAPPENED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654322 ↗
• MalfunctionMar 20, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP WENT UP, THEY OPENED A NEW SUTURE AND THE SAME THING HAPPENED AGAIN. 3 SUTURES WHERE THE SAME THING HAPPENED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654315 ↗
• MalfunctionMar 20, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP WENT UP, THEY OPENED A NEW SUTURE AND THE SAME THING HAPPENED AGAIN. 3 SUTURES WHERE THE SAME THING HAPPENED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654114 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS THAT THE SUTURE DEVICE WAS "PEELING APART" AT THE BARBS. THE SURGEON EXPERIENCED THIS ISSUE ON ALL EXAMPLES OF THAT CODE THAT WERE OPENED FOR THE CASE. HE OPENED A NEW BOX WITH A DIFFERENT LOT THAN WHAT WAS ON THE SUTURE CART IN THE ROOM AND FINISHED THE CASE WITHOUT ISSUE. THE ACCT REQUESTED THAT ALL OPENED BOXES OF THAT CODE THAT WERE ON THE CART BE RETURNED. THE ACTUAL SUTURES BEING USED ON THE PATIENT WERE NOT RETAINED. 19 INDIVIDUAL EACHES WILL BE RETURNED FROM 2 DIFFERENT LOTS. THE PROCEDURE WAS DELAYED BY FIVE 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 21285359 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS THAT THE SUTURE DEVICE WAS "PEELING APART" AT THE BARBS. THE SURGEON EXPERIENCED THIS ISSUE ON ALL EXAMPLES OF THAT CODE THAT WERE OPENED FOR THE CASE. HE OPENED A NEW BOX WITH A DIFFERENT LOT THAN WHAT WAS ON THE SUTURE CART IN THE ROOM AND FINISHED THE CASE WITHOUT ISSUE. THE ACCT REQUESTED THAT ALL OPENED BOXES OF THAT CODE THAT WERE ON THE CART BE RETURNED. THE ACTUAL SUTURES BEING USED ON THE PATIENT WERE NOT RETAINED. 19 INDIVIDUAL EACH WILL BE RETURNED FROM 2 DIFFERENT LOTS. THE PROCEDURE WAS DELAYED BY FIVE 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 21285355 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS THAT THE SUTURE DEVICE WAS "PEELING APART" AT THE BARBS. THE SURGEON EXPERIENCED THIS ISSUE ON ALL EXAMPLES OF THAT CODE THAT WERE OPENED FOR THE CASE. HE OPENED A NEW BOX WITH A DIFFERENT LOT THAN WHAT WAS ON THE SUTURE CART IN THE ROOM AND FINISHED THE CASE WITHOUT ISSUE. THE ACCT REQUESTED THAT ALL OPENED BOXES OF THAT CODE THAT WERE ON THE CART BE RETURNED. THE ACTUAL SUTURES BEING USED ON THE PATIENT WERE NOT RETAINED. 19 INDIVIDUAL EACH WILL BE RETURNED FROM 2 DIFFERENT LOTS. THE PROCEDURE WAS DELAYED BY FIVE 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 21285354 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS THAT THE SUTURE DEVICE WAS "PEELING APART" AT THE BARBS. THE SURGEON EXPERIENCED THIS ISSUE ON ALL EXAMPLES OF THAT CODE THAT WERE OPENED FOR THE CASE. HE OPENED A NEW BOX WITH A DIFFERENT LOT THAN WHAT WAS ON THE SUTURE CART IN THE ROOM AND FINISHED THE CASE WITHOUT ISSUE. THE ACCT REQUESTED THAT ALL OPENED BOXES OF THAT CODE THAT WERE ON THE CART BE RETURNED. THE ACTUAL SUTURES BEING USED ON THE PATIENT WERE NOT RETAINED. 19 INDIVIDUAL EACH WILL BE RETURNED FROM 2 DIFFERENT LOTS. THE PROCEDURE WAS DELAYED BY FIVE 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 21285351 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BROKE AT THE LOOP END. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914927 ↗
• MalfunctionNov 19, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A DIFFERENT SURGEON EXPERIENCED SAME ISSUE NEEDLE POPPING OFF ON THA. THE PROCEDURE WAS DELAYED BY 15 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 20723658 ↗