STRATAFIX SXPP1A400Recalls & reported problems

Summary

The FDA's MAUDE database contains 485 adverse event reports that list this exact device (DI 10705031219366), received between Nov 27, 2017 and Sep 24, 2026 — classified as 82 injuries, 403 malfunctions.

The most frequently reported specific device problem is “Break” (339 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 485 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Break

  Patient problems: Wound Dehiscence

  MAUDE report 50888099 ↗
• MalfunctionSep 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883364 ↗
• MalfunctionSep 24, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It as reported by the account contact to the sales rep that during a knee revision procedure, they had two needle tips breaking off. One broken tip found in the needle driver, and one broken tip found in patient's body. They did not use an X-ray but they were able to retrieve the broken needle. No patient consequences. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883362 ↗
• MalfunctionSep 23, 2026Break

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872929 ↗
• MalfunctionSep 15, 2026Break

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778497 ↗
• MalfunctionAug 14, 2026Break; Material Separation

  It was reported that a patient underwent a Laparoscopic surgery on (b)(6) 2026 and a barbed suture was used on the uterine muscle layer. During the procedure, the surgeon inserted the suture into the abdominal cavity through the puncture hole and found that the problem of pulling off suture needle happened and the tip of the needle was hooked, making it unusable. The suture was immediately removed and replaced with a new one. This incident did not cause substantial harm to the patient, but delayed surgical hemostasis, which affected surgical efficiency. There were no adverse patient consequences. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255021 ↗
• MalfunctionAug 5, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50147398 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT KNEE REPLACEMENT SURGERY IN (B)(6) 2026 AND BARBED SUTURE WAS USED TO SEW THE JOINT CAPSULE. A PERIOD AFTER SURGERY, THE PATIENT CLAIMED PAIN ESPECIALLY ABOVE THE PATELLA AND RETURNED BACK TO HOSPITAL FOR CHECK. IT'S FOUND THE SKIN AND SUBCUTANEOUS TISSUE HEALED WELL, BUT THERE WAS A CAVITY IN THE DEPTH, AND LIQUEFACTION INSIDE. THE PATIENT HAD POOR INCISION HEALING. A SECOND REVISION WAS DONE IN THIS MAY AND MADE DEBRIDEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Pain

  MAUDE report 25480815 ↗
• MalfunctionJun 4, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED DURING THE SURGERY, AND IT OCCURRED AGAIN UNDER INTRAOPERATIVE RISK CONDITIONS, CAUSING THE SURGERY TO BE INTERRUPTED AND THUS PROLONGING THE SURGERY TIME. THE NEW SUTURE WAS IMMEDIATELY REPLACED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394377 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE JOINT REPLACEMENT SURGERY ON (B)(6) 2026 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337805 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE WOUND DEHISCED. THE PATIENT EXPERIENCED VOMITING AND/OR COUGHING AND NOTICED FLUID BUILDUP NEAR THE INCISION SITE, PROMPTING THEM TO RETURN FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Seroma; Vomiting; Wound Dehiscence

  MAUDE report 25245990 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE WOUND DEHISCED. THE PATIENT EXPERIENCED A FALL AT HOME DURING RECOVERY, FELT A POP, AND RETURNED TO THE HOSPITAL FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 25245965 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE WOUND DEHISCED. THE PATIENT EXPERIENCED A FALL AT HOME DURING RECOVERY, FELT A POP, AND RETURNED TO THE HOSPITAL FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 25245958 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6)2026 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.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216506 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2026 AND BARBED 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 25215465 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2026 AND BARBED 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 25215441 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT'S REPORTED THE NEEDLE TIP BROKE DURING ENDOSCOPIC MYOMECTOMY SURGERY. THE NEEDLE TIP FELL OUTSIDE OF PATIENT, AND IT TOOK AROUND 1 HOUR TO LOOK FOR THE BROKEN NEEDLE TIP, WHICH WAS FINALLY FOUND. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149822 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR FUSION SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE SURGICAL PROCEDURE FOR THE PATIENT, THE DOCTOR FOUND THAT THE SUTURE HAD BROKEN AT THE SUTURE CONNECTION AT THE END OF THE NEEDLE, AND SPLIT INTO TWO STRANDS, MAKING IT IMPOSSIBLE TO CONTINUE SUTURING . THE DOCTOR IMMEDIATELY REPLACED THE SUTURE WITH A NEW ONE TO COMPLETE THE SUTURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24876668 ↗
• MalfunctionApr 8, 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 SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818964 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 2 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654798 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED. 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. ACCORDING TO SALE REP'S FEEDBACK, THIS HOSPITAL ADOPTS THE REGULAR VISITING PROCESS, THE SPECIFIC OPERATION TIME AND OPERATOR IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651455 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED. 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. ACCORDING TO SALE REP'S FEEDBACK, THIS HOSPITAL ADOPTS THE REGULAR VISITING PROCESS, THE SPECIFIC OPERATION TIME AND OPERATOR IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651413 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED. 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. ACCORDING TO SALE REP'S FEEDBACK, THIS HOSPITAL ADOPTS THE REGULAR VISITING PROCESS, THE SPECIFIC OPERATION TIME AND OPERATOR IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651410 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) OF 2026 AND BARBED SUTURE WAS USED. 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. ACCORDING TO SALE REP'S FEEDBACK, THIS HOSPITAL ADOPTS THE REGULAR VISITING PROCESS, THE SPECIFIC OPERATION TIME AND OPERATOR IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598349 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED. 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. ACCORDING TO SALE REP'S FEEDBACK, THIS HOSPITAL ADOPTS THE REGULAR VISITING PROCESS, THE SPECIFIC OPERATION TIME AND OPERATOR IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24592131 ↗