STRATAFIX SXMP1B104Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031236677), received between Jan 12, 2022 and Apr 23, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING TOTAL HIP CASE PROCEDURE DURING SUTURING, THE SURGEON APPLIED TENSION TO THE SUTURE MATERIAL, WHICH RESULTED IN THE SUTURE BREAKING WHILE IN USE. NO PATIENT CONSEQUENCES. 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 24972171 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTA PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE,WHEN LIAISING REGARDING A SEPARATE MATTER THAT A STRAND OF STRATAFIX HAD SNAPPED DURING A SURGICAL PROCEDURE. THE SURGICAL CARE PRACTITIONER RESORTED TO CONVENTIONAL METHODS OF THE CLOSURE AS THE CLOSURE COULDN'T BE SECURED WITH THE SNAPPED STRAND OF STRATAFIX , SO THEY INSTEAD SECURED THE REMAINDER OF THEIR CLOSURE USING A REGULAR MONOCRYL. THEY DID NOT ADVISE ON WHETHER THE STRAND OF STRATAFIX THAT HAD STARTED TO SECURE THE WOUND WAS LEFT IN SITU OR REMOVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010027 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6)2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND BROKE. ANOTHER WAS USED AND BROKE AS WELL HALFWAY DURING SUTURING PROCESS. 3RD DEVICE WAS USED TO COMPLETE PROCEDURE. NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298329 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6)2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRAND BROKE. ANOTHER WAS USED AND BROKE AS WELL HALFWAY DURING SUTURING PROCESS. 3RD DEVICE WAS USED TO COMPLETE PROCEDURE. NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298328 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROSTHESIS ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. 5 TO 6 WEEKS AFTER THE PROCEDURE THE PATIENT EXPERIENCED LOCAL SKIN REACTION WITH SCAR DISUNITY AT DIFFERENT SITES OF THE SCARS AND EXPULSION OF THREAD FRAGMENTS. THE SUTURE WOULD BE AT THE ORIGIN OF THIS REACTION EVOKING AN INTOLERANCE. THE PATIENT GOT A REOPERATION. THIS CAUSED PAIN AND UNSIGHTLY SCARS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Pocket Erosion; Scar Tissue; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 16783551 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THEY USED THREE PACKAGES OF THE DEVICE AND THE NEEDLES BROKE DURING CLOSER. IT WAS STATED THAT THERE MIGHT HAVE BEEN SOME TENSION ON THE FIRST ONE BUT NOT THE LAST TWO. ANOTHER BOX WITH DIFFERENT LOT NUMBER WAS USED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375526 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THEY USED THREE PACKAGES OF THE DEVICE AND THE NEEDLES BROKE DURING CLOSER. IT WAS STATED THAT THERE MIGHT HAVE BEEN SOME TENSION ON THE FIRST ONE BUT NOT THE LAST TWO. ANOTHER BOX WITH DIFFERENT LOT NUMBER WAS USED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375523 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THEY USED THREE PACKAGES OF THE DEVICE AND THE NEEDLES BROKE DURING CLOSER. IT WAS STATED THAT THERE MIGHT HAVE BEEN SOME TENSION ON THE FIRST ONE BUT NOT THE LAST TWO. ANOTHER BOX WITH DIFFERENT LOT NUMBER WAS USED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375513 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE BROKE. THEY USED THREE PACKAGES OF THE DEVICE AND THE NEEDLES BROKE DURING CLOSER. IT WAS STATED THAT THERE MIGHT HAVE BEEN SOME TENSION ON THE FIRST ONE BUT NOT THE LAST TWO. ANOTHER BOX WITH DIFFERENT LOT NUMBER WAS USED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375511 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE STRAND BROKE (TORN APART) AT THE LOOP AREA WHILE CLOSING THE SUBCUTICULAR LAYER. ANOTHER SUTURE WAS USED TO COMPLETE THE CLOSURE OF SUBCUTICULAR LAYER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238013 ↗