STRATAFIX SXMP1B118Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031236707), received between Nov 12, 2019 and Aug 12, 2026 — classified as 4 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227425 ↗
• MalfunctionMay 20, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT SURGICAL STAFF FOUND HUMAN HAIR IN THE BARBED SUTURE PACKAGE DURING THE PROCEDURE. NO DELAY OR PATIENT HARM WAS REPORTED. ONE DEVICE IS RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228796 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN SURGEON USE BARBED SUTURE, SUTURE WAS BROKEN DURING OPERATION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25141482 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHILE SUTURING, THE LOOP AFTER THE BARBED SUTURE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049680 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE LOOP WAS BROKEN WHILE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24928137 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANNICULECTOMY PROCEDURE ON (B)(6) 2026 DUE TO INTERTRIGO CANDIDIASIS AND BARBED SUTURE WAS USED ON THE SKIN. POST-OP, THE PATIENT EXPERIENCED A HEMATOMA/HEMORRHAGE. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION ON POST OP DAY 1 AND DEVELOPED RAPID RESPONSE HYPERTENSION AND WAS TRANSFERRED TO STEP DOWN. THE PATIENT HAS RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension

  MAUDE report 24400371 ↗
• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN SURGEON WANT USE BARBED SUTURE, NEEDLE ISOLATE FROM SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096080 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN SURGEON WANT TO USE, FIXATION LOOP IS BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095248 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN THE HCP WAS USING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158805 ↗
• MalfunctionJun 11, 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 BY THE SALES REP THAT DURING TWO CASES, THE ITEM BROKE WHILE SUTURING. CASES WERE COMPLETED WITH LIKE PRODUCT. NO PATIENT HARM WAS REPORTED. PRODUCT IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184169 ↗
• MalfunctionApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD TWO NEEDLES POP OFF THE SUTURES WHILE THEY WERE SUTURING. NO PATIENT CONSEQUENCES WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741281 ↗
• MalfunctionApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THEY HAD TWO NEEDLES POP OFF THE SUTURES WHILE THEY WERE SUTURING. NO PATIENT CONSEQUENCES WAS REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741240 ↗
• MalfunctionApr 1, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE POPPED OFF SUTURE DURING PROCEDURE WHEN CLOSING. PATIENT WAS INVOLVED, BUT NO HARM OR CONSEQUENCES TO PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740462 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMPECTOMY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWEDGE AT THE VERY END OF THE THREAD. CASE WAS COMPLETED BY TYING OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21538259 ↗
• MalfunctionDec 31, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THE DURING AN UNKNOWN ORTHOPEDIC JOINT PROCEDURE THAT DURING SKIN CLOSURE THE NEEDLE DETACHED FROM THE SUTURE STRAND. ANOTHER LIKE DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047939 ↗
• MalfunctionDec 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REDUCTION MAMMOPLASTY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A BREAST REDUCTION, THE NEEDLE BROKE OFF OF THE SUTURE WHILE SUTURING. THE NEEDLE WAS OBTAINED. THE NEEDLE BROKE AFTER PASSING. CASE WAS COMPLETED WITH LIKE DEVICE. NO PATIENT HARM WAS REPORTED. 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 20841933 ↗
• MalfunctionSep 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE NEEDLE AND THREAD AUTOMATICALLY SEPARATE WHEN TAKEN OUT FROM THREAD PLATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224700 ↗
• MalfunctionJan 25, 2024Material Separation; Material Separation

  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 WAS DETACHED FROM SWAGE WHERE THE SUTURE IS ATTACHED TO THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580393 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN HEART PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DEVELOPED A GIANT RED ALLERGIC REACTION ON THE CHEST. THE PATIENT IS CURRENTLY IN THE SAME POSITION. THEY ARE TRYING TO FIGURE OUT IF THEY NEED TO OPEN THE CHEST BACK UP TO REMOVE THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17401888 ↗
• MalfunctionJun 2, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE THE FIXING TAB BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051823 ↗
• InjuryOct 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT MAY HAVE SCRATCHED THEIR HEAD IN THE MIDDLE OF THE NIGHT WHICH CAUSED THE SUTURE TO BREAK. STAPLES MAY HAVE BEEN USED AFTERWARDS. THE PATIENT HAD AN INFECTION PRIOR TO THE PROCEDURE. NO OTHER INFORMATION IS KNOWN AT THIS TIME AND COULD BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15680202 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER SURGERY ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP ON THE END OF THE SUTURE BROKE DURING SKIN CLOSURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13400755 ↗
• MalfunctionNov 2, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12738372 ↗
• InjuryJan 24, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROSCOPY ON (B)(6) 2019 AND BARBED SUTURE WAS USED IN THE INCISION. THE WOUND WAS IRRIGATED PRIOR TO CLOSURE. APPROXIMATELY 5-7 WEEKS POST OP, THE PATIENT PRESENTED WITH SUTURE BREAKDOWN AND INFECTION, AND SUPERFICIAL DEHISCENCE. A SECOND PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9628619 ↗
• MalfunctionNov 12, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPPED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9310036 ↗