STRATAFIX SXPP1B104Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10705031236240), received between Feb 20, 2018 and Aug 6, 2026 — classified as 14 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown orthopedic procedure on an unknown date and a barbed suture was used. Post-op, the patient experienced a wound dehiscence. The wound dehiscence occurred at the center of the incision, involving approximately 3 to 5 stitches. The case did not progress to deep tissue infection. It was opined by the surgeon that suturing was performed with a finer stitch pitch compared to when a different non-barbed suture was used. The patient has been discharged. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50161984 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Total Hip Replacement on an unknown date and a barbed suture was used. Post-op, the patient experienced a wound dehiscence. The wound dehiscence occurred at the center of the incision, involving approximately 3 to 5 stitches. The case did not progress to deep tissue infection. It was opined by the surgeon that suturing was performed with a finer stitch pitch compared to when a different non-barbed suture was used. The wound was fully reopened and re-sutured using nylon suture. The patient has been discharged. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50161983 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown orthopedic procedure on an unknown date and a barbed suture was used. Post-op, the patient experienced a wound dehiscence. The wound dehiscence occurred at the center of the incision, involving approximately 3 to 5 stitches. The case did not progress to deep tissue infection. It was opined by the surgeon that suturing was performed with a finer stitch pitch compared to when a different non-barbed suture was used. The wound was fully reopened and re-sutured using nylon suture. The patient has been discharged. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50161977 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was that a patient underwent a Total Hip Replacement on an unknown date and a barbed suture was used. Post-op, the patient experienced an infection. The physician commented that the foreign body reaction might have occurred because the continuous suturing with the barbed suture resulted in a greater amount of suture material being embedded in the tissue compared to the interrupted suturing with a different suture used previously. Additional information was requested.

  Patient problems: Foreign Body Reaction; Unspecified Infection; Wound Dehiscence

  MAUDE report 50091467 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, WHERE A PLATE WAS PLACED BESIDE THE KNEE, THE SUTURE PROTRUDED. THE SUTURE WAS REMOVED, AND THE WOUND HEALED AFTER SUBCUTANEOUS CLOSURE WITH SUTURE AND DERMAL INTERRUPTED SUTURES. THE SURGEON OPINED THAT ALTHOUGH ANTIMICROBIAL SUTURES ARE RECOMMENDED IN OVERSEAS GUIDELINES AND THEY WOULD PREFER TO USE THEM, THEY PLAN TO REFRAIN FROM USING THEM UNTIL THE CAUSE IS CLARIFIED BECAUSE TWO INFECTIONS AND THREE PROTRUSION CASES HAVE OCCURRED CONSECUTIVELY. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion

  MAUDE report 24470888 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP JOINT PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, ONE WEEK AFTER SURGERY, THE AREA WHERE THE ADDUCTOR MUSCLE WAS SUTURED SHOWED SUPPURATION. THE SUTURE WAS REMOVED, AND THE WOUND HEALED COMPLETELY AFTER RE-CLOSURE WITH SUBCUTANEOUS SUTURE AND DERMAL SUTURE. THE SURGEON OPINED THAT ALTHOUGH ANTIMICROBIAL SUTURES ARE RECOMMENDED IN OVERSEAS GUIDELINES AND THEY WOULD PREFER TO USE THEM, THEY PLAN TO REFRAIN FROM USING THEM UNTIL THE CAUSE IS CLARIFIED BECAUSE TWO INFECTIONS AND THREE PROTRUSION CASES HAVE OCCURRED CONSECUTIVELY. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 24470886 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, AN INFECTION OCCURRED. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 24470368 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, AN INFECTION OCCURRED. NO SAMPLE WILL BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24470367 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR DERMAL SUTURING. POST-OP, DUE TO OSTEOCHONDROSIS, THERE WERE SIGNS OF INFECTION WITH PUS DISCHARGE FROM THE RIGHT WRIST AND RIGHT ANKLE. BECAUSE AN IMPLANT WAS PRESENT, THE SUTURES WERE REMOVED. THE WOUND WAS THEN SUTURED WITH DIFFERENT SUTURES AND AQUACEL WAS APPLIED. THE PATIENT MADE A FULL RECOVERY. THE DOCTOR COMMENTED THAT THE 3-0 SUTURE MIGHT HAVE BEEN TOO THICK FOR A PEDIATRIC PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 24421306 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR DERMAL SUTURING. POST-OP, DUE TO OSTEOCHONDROSIS, THERE WERE SIGNS OF INFECTION WITH PUS DISCHARGE FROM THE RIGHT WRIST AND RIGHT ANKLE. BECAUSE AN IMPLANT WAS PRESENT, THE SUTURES WERE REMOVED. THE WOUND WAS THEN SUTURED WITH DIFFERENT SUTURES AND AQUACEL WAS APPLIED. THE PATIENT MADE A FULL RECOVERY. THE DOCTOR COMMENTED THAT THE 3-0 SUTURE MIGHT HAVE BEEN TOO THICK FOR A PEDIATRIC PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 24421304 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED BY THAT PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE, AND BARBED SUTURE WAS USED. DURING THE SURGERY, THE LOOP OF THE SUTURE WAS DAMAGED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809640 ↗
• MalfunctionJun 25, 2025Material Integrity Problem; Material Integrity Problem

  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 LOOP HAD COME OFF BEFORE USE. ONLY ONE PRODUCT WAS SENT THIS TIME BUT FIVE PRODUCTS HAD THE SAME PROBLEM. (DISCARDED) IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE DURING THE VISUAL INSPECTION OF THE SAMPLE, MARKS LIKELY CAUSED BY A SURGICAL INSTRUMENT WERE NOTED ON THE NEEDLE. THE SUTURE WAS EXAMINED, AND THE WELD OF THE FIRST LOOP WAS FOUND TO BE DETACHED. HOWEVER, THIS MODE OF FAILURE WAS PROBABLY CAUSED BY EXCESSIVE FORCE APPLIED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329024 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AND UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN ALTHOUGH NO EXTRA TENSION WAS APPLIED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029779 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED ON THE DERMIS. DURING THE PROCEDURE, THE LOOP PART WAS BROKEN ALTHOUGH NO EXTRA TENSION WAS APPLIED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22029755 ↗
• MalfunctionApr 24, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THE LOOP HAD BEEN UNTIED BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. DURING VISUAL INSPECTION OF THE SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. MARKS ON THE BODY NEEDLE APPEAR TO BE BY USE OF SURGICAL INSTRUMENT COULD BE OBSERVED. THE SUTURE WAS EXAMINED, BODY FLUIDS WERE FOUND. IN ADDITION, IT WAS OBSERVED THAT THE WELD OF FIRST LOOP WAS DETACHED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901654 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN OPEN ABDOMEN/CHEST SURGERY, THE SUTURE WAS BROKEN DURING USE AND THE PRODUCT COULD NOT BE USED. THIS EVEN OCCURRED CONTINUOUSLY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891531 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN OPEN ABDOMEN/CHEST SURGERY, THE SUTURE WAS BROKEN DURING USE AND THE PRODUCT COULD NOT BE USED. THIS EVEN OCCURRED CONTINUOUSLY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891529 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN OPEN ABDOMEN/CHEST SURGERY, THE SUTURE WAS BROKEN DURING USE AND THE PRODUCT COULD NOT BE USED. THIS EVEN OCCURRED CONTINUOUSLY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891527 ↗
• MalfunctionApr 23, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE LOOP WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. THE LOT NUMBER IS UNKNOWN BECAUSE THERE WAS NO PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891134 ↗
• MalfunctionApr 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND BEFORE USE THAT THE LOOP WAS NOT FORMED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21871755 ↗
• MalfunctionMar 26, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN RESPIRATORY SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRIED TO USE, THE BARB HAS NOT BEEN ATTACHED TO THE SPIRAL. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698112 ↗
• MalfunctionFeb 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE SUTURE WAS DETACHED EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469648 ↗
• MalfunctionAug 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN NEUROSURGERY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN NEUROSURGERY, THE SUTURE AND NEEDLE HAD TAKEN OFF DURING USE. 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 19981665 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. WHEN USE THE PRODUCT, IT WAS FIXED WITH A LOOP, BUT IT CAME LOOSE, SO A NEW PRODUCT WAS USED. NO EFFECTS TO THE PATIENT AND DID NOT AFFECT THE OPERATION TIME THAT MUCH. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19748807 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THERE WAS NO LOOP ATTACHED TO STUMP OF SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504825 ↗