STRATAFIX SXPP1A410Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705031219311), received between Apr 30, 2018 and Sep 25, 2026 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Material Separation” (21 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used. The suture was broken when the surgeon attempted to sew the tissue. The fishbone threads broke continuously during surgery, and all were from the same batch. Total 4 products occurred suture breakage issue. Changed to another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896645 ↗
• MalfunctionSep 25, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and barbed suture was used. The suture was broken when the surgeon attempted to sew the tissue. The fishbone threads broke continuously during surgery, and all were from the same batch. Total 4 products occurred suture breakage issue. Changed to another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896634 ↗
• MalfunctionSep 25, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and barbed suture was used. The suture was broken when the surgeon attempted to sew the tissue. The fishbone threads broke continuously during surgery, and all were from the same batch. Total 4 products occurred suture breakage issue. Changed to another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896631 ↗
• MalfunctionSep 25, 2026Break

  It was reported that a patient underwent an unknown procedure on (b)(6)2026 and barbed suture was used. The suture was broken when the surgeon attempted to sew the tissue. The fishbone threads broke continuously during surgery, and all were from the same batch. Total 4 products occurred suture breakage issue. Changed to another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896625 ↗
• MalfunctionJun 22, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT A JOINT SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. 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. THE LOT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25585368 ↗
• MalfunctionJan 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY DURING USE ON THE PATIENT. 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 24057060 ↗
• MalfunctionSep 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT UPPER LIMB MELANOCYTIC NEVUS EXCISION UNDER LOCAL ANESTHESIA ON 8-AUG2025 AND SUTURE WAS USED. WHEN THE DOCTOR USED SUTURE DURING THE RIGHT UPPER LIMB MELANOCYTIC NEVUS EXCISION UNDER LOCAL ANESTHESIA OPERATION, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN THE LATER STAGE. DUE TO THE HIGH COST OF THE SUTURE, THE DOCTOR REPLACED IT WITH ORDINARY LONG-ACTING SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009001 ↗
• MalfunctionJul 29, 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 NEEDLE BROKE AND THE BROKEN NEEDLE FELL INTO THE PATIENT'S BODY. THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY TO RETRIEVE THE BROKEN NEEDLE. AT THIS MOMENT, THE PATIENT IS STABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22643140 ↗
• MalfunctionJun 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289462 ↗
• MalfunctionJun 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286792 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BYPASS SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR BYPASS SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, SHORT INSERTION WAS OBSERVED IN THE STRAND. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943837 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, THE USE WAS STOPPED BECAUSE THE SUTURE WAS TORN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. LOT NUMBER - 1035MJ - UNKNOWN IF THIS IS THE CORRECT LOT NUMBER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21435114 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE FIXATION TAB CAME OFF DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274370 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE THE DOCTOR WAS SUTURING, THE SUTURE BROKE IN A BRUSHED SHAPE. THE BROKEN SUTURE WAS IMMEDIATELY STOPPED AND NEW SUTURE WAS USED. THIS INCIDENT RESULTED IN AN EXTENSION OF THE SURGERY TIME. POSSIBLE FOREIGN BODY REACTION IN THE WOUND, INCREASING THE ECONOMIC BURDEN ON THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction

  MAUDE report 21100772 ↗
• MalfunctionAug 27, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A SPINE SURGERY, THE DOCTOR ASKED FOR TWO PACKS OF SYMMETRIC SUTURES, AND THE NURSE GAVE HIM TWO PACKS OF SPIRAL SUTURES. THE DOCTOR THEN INSTRUCTED HER TO PUT OUT SYMMETRIC AGAIN, AND THE NURSE PUT OUT TWO PACKAGES OF SYMMETRIC SUTURES. HOWEVER, ONE OF PACKAGES WAS SPIRAL SUTURE. HE AGAIN POINTED OUT TO THE NURSE THAT IT WAS WRONG, BUT THE NURSE SHOWED HIM THE OUTER PACKAGE AND HE WAS ABLE TO CONFIRM THAT IT WAS THE SYMMETRIC PACKAGE. THE NURSE SAID THAT THE SYMMETRIC PACKAGE WAS OPENED AND CONTAINED SPIRAL. BUT THE DOCTOR DID NOT SEE IT BEING PUT OUT, SO THE DOCTOR THOUGHT THAT IT MUST HAVE BEEN THE NURSE'S MISTAKE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076950 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS BROKEN EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. PLEASE TAKE PHOTOS FOR JAPANESE CUSTOMER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806507 ↗
• MalfunctionFeb 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC SURGERY ON 2/14/2024, A BARBED SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURE. THIS HAPPENED IN 2 PRODUCTS IN A ROW. THESE WERE NOT CONTROL RELEASE NEEDLES. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796876 ↗
• MalfunctionFeb 28, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2024, A BARBED SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURE. THIS HAPPENED IN 2 PRODUCTS IN A ROW. THESE WERE NOT CONTROL RELEASE NEEDLES. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18796863 ↗
• MalfunctionDec 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FIXATION BY SYRINGOMYELIA PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURE ON SUBCUTANEOUS. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415737 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON AN UN KNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855397 ↗
• MalfunctionOct 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON AN UN KNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855396 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN AT THE 1ST STITCH DURING USE. THIS EVENT OCCURRED WITH 2 NEEDLES IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854812 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN AT THE 1ST STITCH DURING USE. THIS EVENT OCCURRED WITH 2 NEEDLES IN A ROW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854710 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC SURGERY ON A (B)(6) 2023 AND BARBED SUTURE WAS USED ON THE SUBCUTANEOUS TISSUE. WOUND DEHISCENCE OCCURRED ON (B)(6) 2023. DURING A SURGERY TO CLEAN THE WOUND, THE SURGEON NOTED THAT ONLY IN THE AREA WHERE BARBED SUTURE WAS USED, NECROSIS OF THE TISSUE OCCURRED. A DIFFERENT TYPE OF SUTURE WAS USED IN OTHER AREAS, BUT NO NECROSIS OCCURRED THERE. THE SURGEON THINKS THAT THE SUTURE MATERIAL MAY HAVE CAUSED AN ALLERGIC REACTION THAT LED TO THE NECROSIS. IT IS UNCLEAR WHETHER THE PRODUCT WAS A DIRECT CAUSE OF THIS EVENT. [CURRENT STATUS OF THE PATIENT] THE PATIENT IS IN THE HOSPITAL. [PROGRESS AND TREATMENT DETAILS] CURRENTLY BEING CONFIRMED [SURGEON¿S OPINION ABOUT CAUSAL RELATIONSHIP BETWEEN PRODUCT AND EVENT] NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Necrosis; Wound Dehiscence

  MAUDE report 17716497 ↗
• MalfunctionJul 7, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, AS SOON AS THE FIRST STITCH IS SEWN, THE NEEDLE AND THREAD ARE SEPARATED AND BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278561 ↗