STRATAFIX SXMP1B421Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705031236424), received between Dec 18, 2017 and Sep 1, 2026 — classified as 25 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Break; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543736 ↗
• MalfunctionDec 29, 2025Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025 AND SUTURE WAS USED. THEY ORDERED 4 BOXES SXMP1B421 AND RECEIVED 4 BOXES WITH THE SAME LOT NUMBER. DURING WOUND CLOSURE AFTER TKA THE SUTURE LOOKED AND FELT DIFFERENT. THE BARBES SEEMED DIFFERENT AND THE DIDN¿T HOLD. THE OPENED ALL FOUR BOXES AND TRIED ONE FROM EACH BOX. THEY ALL SEEM TO HAVE THE SAME FAILURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909353 ↗
• MalfunctionDec 29, 2025Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025 AND SUTURE WAS USED. THEY ORDERED 4 BOXES SXMP1B421 AND RECEIVED 4 BOXES WITH THE SAME LOT NUMBER. DURING WOUND CLOSURE AFTER TKA THE SUTURE LOOKED AND FELT DIFFERENT. THE BARBES SEEMED DIFFERENT AND THE DIDN¿T HOLD. THE OPENED ALL FOUR BOXES AND TRIED ONE FROM EACH BOX. THEY ALL SEEM TO HAVE THE SAME FAILURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909344 ↗
• MalfunctionDec 29, 2025Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025 AND SUTURE WAS USED. THEY ORDERED 4 BOXES SXMP1B421 AND RECEIVED 4 BOXES WITH THE SAME LOT NUMBER. DURING WOUND CLOSURE AFTER TKA THE SUTURE LOOKED AND FELT DIFFERENT. THE BARBES SEEMED DIFFERENT AND THE DIDN¿T HOLD. THE OPENED ALL FOUR BOXES AND TRIED ONE FROM EACH BOX. THEY ALL SEEM TO HAVE THE SAME FAILURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909340 ↗
• MalfunctionDec 29, 2025Positioning Failure; Material Integrity Problem; Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON (B)(6) 2025 AND SUTURE WAS USED. THEY ORDERED 4 BOXES SXMP1B421 AND RECEIVED 4 BOXES WITH THE SAME LOT NUMBER. DURING WOUND CLOSURE AFTER TKA THE SUTURE LOOKED AND FELT DIFFERENT. THE BARBES SEEMED DIFFERENT AND THE DIDN'T HOLD. THE OPENED ALL FOUR BOXES AND TRIED ONE FROM EACH BOX. THEY ALL SEEM TO HAVE THE SAME FAILURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909336 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEG LACERATION REPAIR THAT WENT DOWN TO THE FAT LAYER ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. ON (B)(6) 2025, THE PATIENT HAD A REACTION TO THE SUTURE. THE PATIENT HAS RETURNED 2X WITH RED, SWOLLEN AND PAINFUL MOBILE MASS FELT BELOW INCISION. TOPICAL PORTION OF INCISION HEALING NICELY. 2 ROUNDS OF ABX - MASS LESS SWOLLEN BUT STILL VERY PAINFUL. REFERRED TO SURGERY FOR WASH OUT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Local Reaction; Pain; Swelling/ Edema

  MAUDE report 23020527 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22972730 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22971464 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22969604 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. SUTURE STILL THERE 4-6 WEEKS. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22969135 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968887 ↗
• InjurySep 4, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE IS NOT DISSOLVING OR BREAKING DOWN IN THE TIME FRAME THAT IT SHOULD. THE PATIENT WOULD HAVE TO COME BACK. NO ADVERSE IMPACT ON PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968467 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520019 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY ACCOUNT CONTACT THAT DURING SURGERY THE DOCTOR WAS MAKING THE KNOT AND IT BROKE. THIS HAPPENED TWICE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355254 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY ACCOUNT CONTACT THAT DURING SURGERY THE DOCTOR WAS MAKING THE KNOT AND IT BROKE. THIS HAPPENED TWICE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355175 ↗
• MalfunctionNov 19, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE WIRE HAS NO SELF-LOCKING EFFECT BECAUSE IT HAS NO ANCHORS (IT IS SMOOTH). THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723693 ↗
• MalfunctionAug 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DID NOT HAVE A FUNCTIONING LOOP TO FASTEN THE SUTURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923636 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE WAS PREMATURELY BREAKING WHEN PULLED UNDER TENSION. ANOTHER LIKE DEVICE WAS USED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632732 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE WAS PREMATURELY BREAKING WHEN PULLED UNDER TENSION. ANOTHER LIKE DEVICE WAS USED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632730 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE WAS PREMATURELY BREAKING WHEN PULLED UNDER TENSION. ANOTHER LIKE DEVICE WAS USED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632723 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE WAS PREMATURELY BREAKING WHEN PULLED UNDER TENSION. ANOTHER LIKE DEVICE WAS USED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632719 ↗
• MalfunctionJun 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE THREAD PULLED OFF FROM THE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575676 ↗
• MalfunctionApr 17, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. SUTURE BROKE DURING SUTURING INTRA OPERATIVELY. NO FRAGMENTS WERE GENERATED. NEW SUTURE WAS USED FOR CLOSING. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127594 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF ONE MINUTE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046456 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING USE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF ONE MINUTE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19046170 ↗