STRATAFIX SXPP1B417Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705031236172), received between Jun 20, 2018 and Nov 22, 2022 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND BARBED SUTURE WAS USED. THE DOCTOR USED SUTURE AS INDICATED, HOWEVER, THE SUTURE WAS UNABLE TO HOLD THE TISSUES TOGETHER. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845531 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN INFECTION. THE SURGEON OPINED THE INFECTION MAY HAVE BEEN CAUSED BY THE SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14492516 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REDUCTION OR RECONSTRUCTIVE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP THE PATIENT EXPERIENCED DEHISCENCE. IT WAS REPORTED THAT THE PATIENT CURRENT STATUS IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 11135388 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REDUCTION OR RECONSTRUCTIVE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP THE PATIENT EXPERIENCED DEHISCENCE. IT WAS REPORTED THAT THE PATIENT CURRENT STATUS IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 11135174 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REDUCTION OR RECONSTRUCTIVE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP THE PATIENT EXPERIENCED DEHISCENCE WHICH RESULTED IN INFECTION. THE SURGEON DID NOT INDICATE HOW THE INFECTION WAS TREATED. IT WAS REPORTED THAT THE PATIENT CURRENT STATUS IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 11134924 ↗
• MalfunctionJun 20, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING DEEP DERMIS TISSUE, IN A CONTINUOUS BARB CLOSURE, THE NEEDLE BROKE, THREE QUARTERS OF THE WAY UP THE NEEDLE FROM THE SUTURE STRAND. THE NEEDLE TIP WAS RETRIEVED AND SAVED, ALONG WITH THE REMAINING NEEDLE AND SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7619797 ↗