STRATAFIX SXMP1B107Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031236592), received between Sep 30, 2022 and Sep 3, 2026 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Total Knee Arthroplasty (TKA) procedure on (b)(6) 2026 and a barbed suture was used. Post-op, the patient experienced a wound dehiscence. The surgeon opined the product may have contributed to the wound dehiscence. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50590502 ↗
• InjuryJul 7, 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 ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE PATIENT HAD TO GO BACK TO SURGERY BECAUSE THE SURGERY CENTER OPENED UP. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED,

  Patient problems: Wound Dehiscence

  MAUDE report 22410849 ↗
• InjuryJun 26, 2025Break; 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 9-JUN-2025 AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT WENT TO THE ER THE NIGHT OF THE PROCEDURE AND THE PATIENT WAS BROUGHT BACK TO THE OR THE NEXT DAY WITH A WOUND DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 22341612 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT JUST POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341611 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT JUST POPPED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341610 ↗
• MalfunctionAug 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED ON (B)(6) 2024 AFTER RECEIVING SOME PRODUCT SAMPLES UPON OPENING IT WAS FOUND THAT THERE WAS NO PRODUCT INSERT IN THE BOXES. THE BOXES HAVE QR CODES ON IT BUT IT DOES NOT WORK. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906521 ↗
• MalfunctionAug 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED ON (B)(6) 2024 AFTER RECEIVING SOME PRODUCT SAMPLES UPON OPENING IT WAS FOUND THAT THERE WAS NO PRODUCT INSERT IN THE BOXES. THE BOXES HAVE QR CODES ON IT BUT IT DOES NOT WORK. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906493 ↗
• MalfunctionAug 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED ON 7/8/2024 AFTER RECEIVING SOME PRODUCT SAMPLES UPON OPENING IT WAS FOUND THAT THERE WAS NO PRODUCT INSERT IN THE BOXES. THE BOXES HAVE QR CODES ON IT BUT IT DOES NOT WORK. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906464 ↗
• MalfunctionAug 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED ON 7/8/2024 AFTER RECEIVING SOME PRODUCT SAMPLES UPON OPENING IT WAS FOUND THAT THERE WAS NO PRODUCT INSERT IN THE BOXES. THE BOXES HAVE QR CODES ON IT BUT IT DOES NOT WORK. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906460 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED TO CLOSE THE SKIN. THE PATIENT EXPERIENCED AN INFLAMED SCAR A STITCH SINUS AFTER 4-6 WEEKS FROM SURGERY. IT OCCURRED AGGRESSIVELY WITH THE PATIENT. THE SURGEON HAD TO RE-OPERATE ON THE PATIENT TO EXCISE THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Insufficient Information; Wound Dehiscence

  MAUDE report 16712874 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED TO CLOSE THE SKIN. THE PATIENT EXPERIENCED AN INFLAMED SCAR A STITCH SINUS AFTER 4-6 WEEKS FROM SURGERY. IT OCCURRED AGGRESSIVELY WITH THE PATIENT. THE SURGEON HAD TO RE-OPERATE ON THE PATIENT TO EXCISE THE WOUND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation; Insufficient Information; Wound Dehiscence

  MAUDE report 16712868 ↗
• MalfunctionApr 4, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A CABG THE SUTURE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678266 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DEVELOPED A WOUND INFECTION AND THE WOUND ¿FELL APART¿ AT NINE DAYS POST OP. TREATMENT IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 15514892 ↗