STRATAFIX SXMP1B413Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10705031236417), received between Jun 11, 2018 and Sep 3, 2026 — classified as 30 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 55 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown OB/GYN procedure on an unknown date and a barbed suture was used for perineal suturing. Nine days post-op, wound dehiscence was observed in the patient. Additional treatment of suturing with a different suture was performed on the perineal dehiscence area. , Currently there are no particular problems with the patient's condition. The physician opined that it was unclear whether an inflammatory response at the wound site led to the dehiscence or if the dehiscence itself triggered the inflammation. Additional information was requested.

  Patient problems: Inflammation; Wound Dehiscence

  MAUDE report 50589166 ↗
• MalfunctionSep 3, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, COMPLAINT: 3 SEPARATE SUTURES WERE USED AND ALL 3 HAD THE SAME ISSUES. THE BARBS DIDN¿T HOLD IN THE TISSUE. THEY OPENED AN ALTERNATIVE BOX WITH A DIFFERENT LOT AND THEY DIDN¿T HAVE THE SAME ISSUE. NO ADVERSE PATIENT REACTIONS, THE SUTURES WERE REMOVED AND NOT LEFT IN THE PATIENT. ALTERNATIVE SUTURES WERE USED TO CLOSE ON THE 3 OCCASIONS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953285 ↗
• MalfunctionSep 3, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, COMPLAINT: 3 SEPARATE SUTURES WERE USED AND ALL 3 HAD THE SAME ISSUES. THE BARBS DIDN¿T HOLD IN THE TISSUE. THEY OPENED AN ALTERNATIVE BOX WITH A DIFFERENT LOT AND THEY DIDN¿T HAVE THE SAME ISSUE. NO ADVERSE PATIENT REACTIONS, THE SUTURES WERE REMOVED AND NOT LEFT IN THE PATIENT. ALTERNATIVE SUTURES WERE USED TO CLOSE ON THE 3 OCCASIONS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953284 ↗
• MalfunctionSep 3, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED AN ANIMAL UNDERWENT AN UNKNOWN VETERINARY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, COMPLAINT: 3 SEPARATE SUTURES WERE USED AND ALL 3 HAD THE SAME ISSUES. THE BARBS DIDN¿T HOLD IN THE TISSUE. THEY OPENED AN ALTERNATIVE BOX WITH A DIFFERENT LOT AND THEY DIDN¿T HAVE THE SAME ISSUE. NO ADVERSE PATIENT REACTIONS, THE SUTURES WERE REMOVED AND NOT LEFT IN THE PATIENT. ALTERNATIVE SUTURES WERE USED TO CLOSE ON THE 3 OCCASIONS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953274 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING SUBCUTIS LAYER CLOSURE, THE SUTURE BROKE. THE SURGERY DELAYED DUE TO THE REPORTED EVENT BY 1 MINUTE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994328 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING SUBCUTIS LAYER CLOSURE, SUTURE BROKE. THE SURGERY DELAYED DUE TO THE REPORTED EVENT BY 1 MINUTE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994285 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SNAPS DURING PULLING THROUGH THE TISSUE. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989806 ↗
• MalfunctionNov 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. IN THE SAME DAY FOR 3 PATIENTS 4 SUTURE NEEDLES CAME AWAY FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775259 ↗
• MalfunctionNov 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. IN THE SAME DAY FOR 3 PATIENTS 4 SUTURE NEEDLES CAME AWAY FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774797 ↗
• MalfunctionNov 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. IN THE SAME DAY FOR 3 PATIENTS 4 SUTURE NEEDLES CAME AWAY FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773917 ↗
• MalfunctionNov 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. IN THE SAME DAY FOR 3 PATIENTS 4 SUTURE NEEDLES CAME AWAY FROM THE THREAD. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773456 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601698 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601697 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601115 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601112 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601093 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601090 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601038 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601032 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE CLOSING, THE PA WAS SUTURING NORMALLY AND THE STRING BROKE IN TWO. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601026 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247736 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED ON THE SKIN. PHYSICIAN STATED THAT MULTIPLE STANDS OF STRATAFIX MONOCRYL BROKE DURING SKIN CLOSURES. THE PHYSICIAN STATED THAT THEY WERE NOT PULLING HARD ON THE SUTURE AND THEY SNAPPED. THERE WAS NO PATIENT HARM. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922035 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. PHYSICIAN STATED THAT MULTIPLE STANDS OF STRATAFIX MONOCRYL BROKE DURING TKA SKIN CLOSURES. THEY WERE ABLE TO RETAIN TWO BROKEN STRANDS. THE PHYSICIAN STATED THAT THEY WERE NOT PULLING HARD ON THE SUTURE AND THEY SNAPPED. THERE WAS NO PATIENT HARM. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921152 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. PHYSICIAN STATED THAT MULTIPLE STANDS OF STRATAFIX MONOCRYL BROKE DURING TKA SKIN CLOSURES. THEY WERE ABLE TO RETAIN TWO BROKEN STRANDS. THE PHYSICIAN STATED THAT THEY WERE NOT PULLING HARD ON THE SUTURE AND THEY SNAPPED. THERE WAS NO PATIENT HARM. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921151 ↗
• MalfunctionSep 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR OPEN PROCEDURE ON (B)(6) 2023, AND BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17751947 ↗