STRATAFIX SXMP1B417Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031236332), received between Jan 18, 2019 and Jul 27, 2022 — classified as 3 injuries, 1 malfunction.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING WOUND CLOSURE A 2-0 STRATAFIX SUTURE BROKE. DUE TO THE NATURE OF THE BARBED SUTURE AND THE DIRECTION OF THE SURGEON, CLOSURE WAS SUSPENDED. PA REMOVED THE 2-0 AND 0 STRATAFIX, AS WELL THE 0 VICRYL FROM THE WOUND. WOUND CLOSURE WAS RESUMED UTILIZING 0 VICRYL, 2-0 VICRYL, 3-0 MONOCRYL AND 3-0 NYLON. THIS ADDED APPROXIMATELY 20 MINUTES TO THE CASE. SUTURE ACTUALLY BROKE WHEN PATIENT WAS ABOUT 2/3 OF THE WAY CLOSED. IT WAS REPORTED THAT THE SUTURE BROKE SOMEWHERE NEAR THE END. A SUTURE PASS WAS MADE AND WHEN PULLED OUT, IT BROKE. MINIMAL TENSION APPLIED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15116801 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE SURGEON NOTED PATIENT HAD REDNESS, SWELLING AND GENERAL UNWELL LOOKING INCISION. IT WAS REPORTED SUSPECTED INFECTION AND PATIENT WAS ADMITTED TO CARE FACILITY AND NOT SEEMING TO RESPOND TO ANTIBIOTICS. THE SURGEON OPINED ISSUE IS WITH INCISION AND PATIENT HAS HAD REDNESS SINCE DAY ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Inflammation; Not Applicable; Swelling; Unspecified Infection

  MAUDE report 10464946 ↗
• InjuryJan 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON UNKNOWN DATE IN (B)(6) 2018 AND BARBED SUTURE WAS USED TO CLOSE THE OUTER LAYER OF SKIN TISSUE. THE PATIENT EXPERIENCED WOUND DEHISCENCE TWO WEEKS POST PROCEDURE. A SECOND PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE TO CLOSE THE WOUND WITH UNKNOWN SUTURE. THE PATIENT CURRENT STATUS IS REPORTED AS DISCHARGED AND IS DOING FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 8264792 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON UNKNOWN DATE IN (B)(6) 2018 AND BARBED SUTURE WAS USED TO CLOSE THE OUTER LAYER OF SKIN TISSUE. THE PATIENT EXPERIENCED WOUND DEHISCENCE TWO WEEKS POST PROCEDURE. A SECOND PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE TO CLOSE THE WOUND WITH UNKNOWN SUTURE. THE PATIENT CURRENT STATUS IS REPORTED AS DISCHARGED AND FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 8262554 ↗