STRATAFIX SXMP1B111Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10705031236660), received between Oct 30, 2020 and May 21, 2026 — classified as 14 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING INCISION CLOSED THE TIP OF STRATAFIX MONOCRYL 3-0 SPIRAL PS NEEDLE BROKE OFF INSIDE PATIENTS WOUND. IT WAS DISCOVERED DURING SUTURING AS SURGEON NOTICED THE TIP OF THE NEEDLE WAS MISSING. LOT # NOT VERIFIABLE AS MULTIPLE OF SAME SUTURE FROM DIFFERENT BOXES/LOTS USED IN THE SAME PROCEDURE. PRODUCT DISCARDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241851 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE THREAD DETACHED FROM THE NEEDLE DURING SURGERY. HALFWAY THROUGH CLOSING THE SKIN, THE SUTURE THREAD DETACHED FROM THE NEEDLE, THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152038 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ON TWO OCCASIONS, WHEN ORTHO SURGEON WAS USING STRATAFIX SPIRAL MONOCRYL, THE LOOP BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090263 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ON TWO OCCASIONS, WHEN ORTHO SURGEON WAS USING STRATAFIX SPIRAL MONOCRYL, THE LOOP BROKE OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090253 ↗
• MalfunctionMay 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON WENT TO USE THE SUTURE, THE THREAD POPPED OFF THE NEEDLE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011243 ↗
• MalfunctionMay 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN SURGEON WENT TO USE THE SUTURE, THE THREAD POPPED OFF THE NEEDLE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011237 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. MIGRATION OF THE SUBCUTANEOUS SPIRAL SUTURE. THE PATIENT NEEDS TO BE REINTERVENED, AS THEY REJECT THE DEVICE. THE PATIENT REJECTS DEVICE AND THE SUTURE MIGRATES FROM THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21538168 ↗
• MalfunctionFeb 26, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE - NEEDLE WAS DULL AND SURGEON FELT IT DID NOT CUT AS PER USUAL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471758 ↗
• MalfunctionFeb 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE CAME OFF SUTURE DURING SKIN CLOSURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428579 ↗
• MalfunctionJan 28, 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 CAME OFF SUTURE. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252120 ↗
• MalfunctionJan 28, 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 CAME OFF SUTURE. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252119 ↗
• MalfunctionAug 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLE BROKE FROM SUTURE AFTER GOING THROUGH TISSUE. THE SURGEON HAD TO OPEN ANOTHER DEVICE TO FINISH SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19885405 ↗
• MalfunctionAug 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE NEEDLE BROKE FROM SUTURE AFTER GOING THROUGH TISSUE. THE SURGEON HAD TO OPEN ANOTHER DEVICE TO FINISH SUTURING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19885395 ↗
• MalfunctionAug 1, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPAIR PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. WHILE THE DOCTOR WAS DOING THE PROCEDURE, THE SUTURE BROKE. THE SURGEON TOOK ANOTHER ONE, AND IT BROKE AS WELL. JUST AS THE DOCTOR WOULD PASS THROUGH TISSUE AND PULL, IT WOULD BREAK. FRAGMENTS WERE GENERATED BUT EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19884557 ↗
• MalfunctionAug 1, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPAIR PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. WHILE THE DOCTOR WAS DOING THE PROCEDURE, THE SUTURE BROKE. THE SURGEON TOOK ANOTHER ONE, AND IT BROKE AS WELL. JUST AS THE DOCTOR WOULD PASS THROUGH TISSUE AND PULL, IT WOULD BREAK. FRAGMENTS WERE GENERATED BUT EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19884476 ↗
• MalfunctionMar 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WOULD BREAK FROM THE NEEDLE OR WHEN THEY WOULD DO FINISH THEIR LAST PASS, SAME THING WOULD HAPPEN. THIS HAPPENED SEVERAL TIMES RECENTLY BUT WE WERE ABLE TO RECOVER 2 FAULTY SUTURES. CUSTOMER WOULD LIKE TO RETURN ALL BOXES THAT WERE FROM THE SAME LOT AS A PRECAUTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963566 ↗
• MalfunctionMar 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NURSE CONFIRMED THAT ONE OF THE SUTURES FROM (B)(4) WAS USED IN A DIFFERENT ORTHOPEDIC CASE. SUTURE (STRATAFIX SPIRAL MONOCRYL PLUS) BROKE OFF FROM NEEDLE WHILE TAKING A PASS IN TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963529 ↗
• MalfunctionMar 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WOULD BREAK FROM THE NEEDLE OR WHEN THEY WOULD DO FINISH THEIR LAST PASS, SAME THING WOULD HAPPEN. THIS HAPPENED SEVERAL TIMES RECENTLY BUT WE WERE ABLE TO RECOVER 2 FAULTY SUTURES. CUSTOMER WOULD LIKE TO RETURN ALL BOXES THAT WERE FROM THE SAME LOT AS A PRECAUTION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963472 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY PROCEDURE IN (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, AT FIRST PASS OF THE SUTURE IN TISSUE, SUTURE BROKE. THEY PUT SUTURE AND NEEDLE ASIDE AND TOOK ANOTHER SUTURE, SAME CODE AND BOX, ALL WENT WELL. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17944275 ↗
• InjuryApr 29, 2022Adverse 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 SUTURE WAS USED. POST-OP, THE PATIENT HAD A SCARRING PROBLEM. THE PATIENT HAD A PROFOUND INFECTION WHICH REQUIRED A REVISION PROCEDURE FOR ABSCESS DRAINAGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Scar Tissue; Unspecified Infection

  MAUDE report 14251914 ↗
• InjuryApr 29, 2022Adverse 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 SUTURE WAS USED. POST-OP, THE PATIENT HAD A SCARRING PROBLEM. THE PATIENT HAD A SUPERFICIAL INFECTION TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Scar Tissue; Unspecified Infection

  MAUDE report 14251866 ↗
• InjuryApr 29, 2022Adverse 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 SUTURE WAS USED. POST-OP, THE PATIENT HAD A SCARRING PROBLEM. THE PATIENT HAD A SUPERFICIAL INFECTION TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Scar Tissue; Unspecified Infection

  MAUDE report 14251861 ↗
• InjuryApr 29, 2022Adverse 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 SUTURE WAS USED. POST-OP, THE PATIENT HAD A SCARRING PROBLEM. THE PATIENT HAD A SUPERFICIAL INFECTION TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Scar Tissue; Unspecified Infection

  MAUDE report 14251860 ↗
• InjuryApr 29, 2022Adverse 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 SUTURE WAS USED. POST-OP, THE PATIENT HAD A SCARRING PROBLEM. THE PATIENT HAD A PROFOUND INFECTION WHICH REQUIRED A REVISION PROCEDURE FOR ABSCESS DRAINAGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Scar Tissue; Unspecified Infection

  MAUDE report 14251853 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROSCOPY ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. ON (B)(6) 2021, THE PATIENT CALLED THE OFFICE OF THE PROVIDER WITH CONCERNS ABOUT THEIR INCISION. ON (B)(6) 2021, THE PATIENT WAS SEEN IN THE CLINIC AND HAD WOUND DEHISCENCE AT THE PROXIMAL AND DISTAL ENDS OF THE INCISION. THE PATIENT POSSIBLY EXPERIENCED LOCAL REDNESS AND PUS. THE PATIENT WAS INSTRUCTED TO APPLY BETADINE TWICE A DAY. ON (B)(6) 2022, THE PATIENT WAS SEEN IN THE OFFICE AND IT WAS DETERMINED THAT IRRIGATION AND DEBRIDEMENT WAS NOT NECESSARY. THE SUTURE TAILS WERE REMOVED IN THE AREAS OF DEHISCENCE. THE INCISION IS CURRENTLY HEALING WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Purulent Discharge; Skin Inflammation/ Irritation; Wound Dehiscence

  MAUDE report 13423845 ↗