STRATAFIX SXPP1B414Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031235878), received between Sep 5, 2018 and May 6, 2022 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022. AND BARBED SUTURE WAS USED. IT WAS STATED THAT THE LOOP WAS BROKEN THEN ANOTHER DEVICE WAS USED AND WAS HALF CUT AND DIDN'T HOLD A THING. THE PROCEDURE WAS COMPLETED BY TYING IT WITH A KNOT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310624 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES HAD 'NEEDLES BREAKING IN HALF AND ENDS NOT HOLDING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286663 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES HAD 'NEEDLES BREAKING IN HALF AND ENDS NOT HOLDING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283674 ↗
• InjuryMar 26, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2019 AND SUTURE WAS USED. THE PATIENT IS AN AMBIENT USER AND WHEN SHE WOKE TO USE THE RESTROOM HER KNEE FLEXED, AND SHE FELL BREAKING OPEN THE SUBCUTICULAR LAYER OF STITCHES CAUSING A DEHISCENCE. THE PATIENT RETURNED TO HAVE THE WOUND RE-STITCHED. THE PATIENT CURRENT STATUS IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 8454619 ↗
• InjuryDec 18, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED POST OP SUTURE BREAKAGE THREE DAYS POST OP. IT WAS REPORTED THAT THE BARBS WERE NOTED TO BE INTACT AND THE STITCH POPPED OUT OF THE SKIN. THE SUTURE WAS CUT OUT IN THE OFFICE ON AN UNKNOWN DATE. THE PATIENT IS REPORTED AS DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 8175448 ↗
• InjuryDec 18, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINE PROCEDURE ON UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED POST OP SUTURE BREAKAGE THREE DAYS POST OP. IT WAS REPORTED THAT THE BARBS WERE NOTED TO BE INTACT AND THE STITCH POPPED OUT OF THE SKIN. THE SUTURE WAS CUT OUT IN THE OFFICE ON AN UNKNOWN DATE. THE PATIENT IS REPORTED AS DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 8175418 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE SUTURE BEGAN TO ¿SPIT¿ AND EVENTUALLY PATIENT WAS BROUGHT IN FOR RE-OP AND WASH-OUT ABOUT SIX TO EIGHT-WEEK POST OP. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8130249 ↗
• MalfunctionSep 5, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROPEXY PROCEDURE ON (B)(6) 2018 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS NOT HOLDING AND WAS SLIDING BACKWARDS THROUGH THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7845354 ↗