STRATAFIX SXPP1A304Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031245297), received between Feb 3, 2023 and Aug 17, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Material Separation

  It was reported that a patient underwent an unknown orthopedic procedure on an unknown date and barbed suture was used. During an unknown orthopedic surgery, the suture was detached from the needle easily when trying to grasp it with the needle holder. The product could not be used. 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 50277842 ↗
• MalfunctionAug 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE WHEN TRYING TO USE IT IN OPERATION. 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 22707985 ↗
• InjuryFeb 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUBTOTAL STOMACH-PRESERVING PANCREATODUODENECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE METHOD WAS CONTINUOUS SUTURE. THE PATIENT DEVELOPED A SEVERE SURGICAL SITE INFECTION. ABOUT 3 WEEKS AFTER THE SURGERY, THE WOUND WAS DEHISCENT AND IT WAS FOUND THAT THE PRODUCT WAS BROKEN. THE SURGEON STATED THEY ARE AWARE OF THE RISK OF DEHISCENCE BECAUSE OF THE WOUND SSI, BUT THE PRODUCT BROKE 3 WEEKS AFTER SURGERY AND THE PATIENT WAS A 81 YEAR-OLD WOMAN WHO HAS NO STRONG ABDOMINAL MUSCLES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Inflammation; Insufficient Information; Unspecified Infection; Wound Dehiscence

  MAUDE report 16292994 ↗