STRATAFIX SXPP1A444Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10705031245235), received between Apr 1, 2020 and Sep 23, 2026 — classified as 13 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Break” (44 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used. The needle broke in the middle. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873251 ↗
• MalfunctionAug 19, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331109 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a child underwent a scoliosis procedure on (b)(6) 2026 and barbed suture was used for closure. They took the patient back to the OR 10 days later due to persistent wound drainage. The barbed suture shredded his fascia due to the size of the barbs. Surgery was performed to fix the closure. Additional information was requested.

  Patient problems: Fluid Discharge; Unspecified Tissue Injury

  MAUDE report 50082112 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25217123 ↗
• MalfunctionMay 12, 2026Device Markings/Labelling Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE PACKAGES DO NOT LOOK THE SAME. THEY¿RE MISSING INFORMATION AND THE CUSTOMER IS WONDERING WHY SOME SYMBOLS ARE NOT ON THE OUTER AND INNER PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148484 ↗
• MalfunctionApr 21, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24943191 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926743 ↗
• MalfunctionMar 24, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE NEEDLE WAS BENT DURING USE. ALSO, ITS TIP BROKE OFF. THE TIP WAS REMOVED FROM THE PATIENT. THERE WERE NO SIGNIFICANT DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680267 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DURING PROCEDURE, USING A STRATAFIX, THE NEEDLE BENT FROM THE MIDDLE ACCORDING TO PICTURE. THEY TRIED TO USE ANOTHER ONE, SAME LOT WITH THE SAME OUTCOME. PATIENT CONSEQUENCES: NONE. THE PROCEDURE WAS DELAYED WITH 10-15 MINUTES. LOT : 1096LC, CODE: SXPP1A444. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS A NEEDLE HELD WITH A SURGICAL NEEDLE; IT APPEARS PARTIALLY BROKEN SEVERAL TOOLING MARKS WERE OBSERVED TROUGH THE NEEDLE BODY. AS WITH ANY DEVICE, CARE MUST BE TAKEN TO AVOID DAMAGING THE NEEDLE WHEN HANDLING IT. AVOID CRUSHING OR CRIMPING ACTION OF SURGICAL INSTRUMENTS SUCH AS NEEDLE HOLDERS AND FORCEPS. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643506 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. APPROXIMATELY 3 MM OF SUTURE TIP FROM SUTURE BROKE OFF INTRA-OPERATIVELY. NO FOREIGN BODY DETECTED USING X-RAY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313217 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE GOT PULLED OFF FROM THE INCISION BEFORE THEY COULD SUTURE IT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073830 ↗
• MalfunctionDec 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN L3-S1 LUMBAR INTERNAL FIXATION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN SUTURING WOUND. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898782 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING TO HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT; NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854578 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING TO HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT; NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854571 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851267 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851242 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851237 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851188 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING TO HCP, APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT; NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851156 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850817 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850789 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. NEEDLE BREAKAGE DURING USE. ACCORDING HCP APPROXIMATELY 30 TIMES. A SMALL PIECE OF THE TIP BROKE OFF. ALL THE TIPS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, NO PART REMAIN IN PATIENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850769 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819376 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 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. SURGERY: JOINT REPLACEMENT SURGERY .NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647828 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG WITH AVR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE THE BARBED SUTURES BROKE DURING SUTURING. IT WAS REPORTED THAT A NEEDLE BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310208 ↗