STRATAFIX SXPP1A200Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031227668), received between Nov 27, 2018 and Aug 3, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used. The stitches tore postoperatively, which is why a revision was necessary. The patient is all good, because capsule has been re-sewn. Additional information has been requested.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 50114684 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY: TKA ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB CAME OFF THE SUTURE WITH THE FIRST FIXATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013203 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY: TKA ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB CAME OFF THE SUTURE WITH THE FIRST FIXATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013202 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE FASCIA OF THE KNEE JOINT WAS SUTURED, THE FIRST STITCH WAS MADE, AND THE FASCIA WAS EASILY DETACHED FROM THE TAB WHEN IT WAS PULLED OVER THE FIXATION TAB. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451202 ↗
• MalfunctionDec 29, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE POPPED OFF OF THREE SUTURES. NEW SUTURES WERE 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 16075324 ↗
• MalfunctionDec 13, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. WHEN THE NEEDLE WAS PASSING THROUGH THE FIRST TIME, THE SURGEON NOTICED THAT THE END FIXATION TAB HAD BEEN BROKEN. THE SURGEON DIDN¿T PULL THE PRODUCT STRONGLY AND IT WAS POSSIBLE THAT THE FIXATION TAB WAS ALREADY BROKEN WHEN OPENING THE PACKAGE. THE PRODUCT WAS USED ON BUTTOCKS AND FASCIA. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971674 ↗
• MalfunctionMay 11, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS NOTICED THAT THERE WAS ONLY A HALF OF THE FIXATION TAB BEFORE USE, SO IT WAS NOT USED FOR THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366290 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WERE TWO KNOTS AT THE FIXATION TAB. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13932490 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13526959 ↗
• MalfunctionJul 20, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN AFTER PASSING 1 STITCH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196182 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966760 ↗
• MalfunctionApr 16, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE FIXATION TAB HAD BEEN BROKEN. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE FIXATION FEATURE WAS BROKEN DURING USE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679584 ↗
• MalfunctionDec 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6)2020 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN PUTTING THE 1ST STITCH ON THE FASCIA, THE SUTURE GOT DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003806 ↗
• MalfunctionJan 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND BARBED SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9598404 ↗
• MalfunctionDec 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS TORN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9395137 ↗
• MalfunctionMar 20, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. SIX WEEKS FOLLOWING THE PROCEDURE, A DEHISCENCE OCCURRED. THE SUTURE SEEMED TO BE BROKEN AT THE INSIDE OF THE VASTUS MEDIALIS, AND THE WOUND WAS OPENED IN THE PATIENT¿S BODY. THE PATIENT COULD NOT EXTEND HIS KNEE FIRMLY. THERE WAS A DENT ON THE UPPER EDGE OF THE PATELLA. THE SURFACE LAYER OF THE SKIN WAS NOT DEHISCED. THERE WAS A POSSIBILITY THAT THE SUTURE WAS BROKEN INSIDE THE BODY, BUT IT COULD NOT BE CONFIRMED BY MRI DUE TO HALATION. NO ADDITIONAL TREATMENT WAS PERFORMED. SINCE REOPERATION HAS NOT BEEN DONE, IT IS UNKNOWN ONE OR BOTH SUTURE WAS BROKEN. THERE IS NO PLAN TO RE-OPERATE, BECAUSE THERE IS A FEAR OF INFECTION. THE PATIENT WAS CURRENTLY REPORTED AS BEING IN THE HOSPITAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436081 ↗
• MalfunctionMar 19, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. FOUR WEEKS FOLLOWING THE PROCEDURE, A DEHISCENCE OCCURRED. THE SUTURE SEEMED TO BE BROKEN AT THE INSIDE OF THE VASTUS MEDIALIS, AND THE WOUND WAS OPENED IN THE PATIENT¿S BODY. THE PATIENT COULD NOT EXTEND HIS KNEE FIRMLY WHEN TRYING TO EXTEND. WHEN PUSH ON THE UPPER EDGE OF THE PATELLA WITH FINGERS, IT IS DENTED. THE SURGEON OPINED THERE WAS A HIGH POSSIBILITY THAT THE SUTURE WAS BROKEN UNDER THE SKIN. NO ADDITIONAL TREATMENT WAS PERFORMED AND THERE IS NO PLAN TO RE-OPERATE FOR FEAR OF INFECTION. SINCE RE-OPERATION HAS NOT BEEN DONE, IT IS UNKNOWN WHETHER THE SUTURE WAS BROKEN. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS DISCHARGED FROM THE HOSPITAL AND REGULARLY VISITS THE HOSPITAL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432846 ↗
• MalfunctionDec 12, 2018Separation Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP PROCEDURE ON (B)(6) 2018, AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS STARTING TO SUTURE FASCIA TISSUE, IN A CONTINUOUS LOOP, AND THE SUTURE SEPARATED FROM THE NEEDLE. A SECOND LIKE SUTURE STRAND WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155930 ↗
• MalfunctionNov 27, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE WHEN HOLDING THE NEEDLE WITH A NEEDLE HOLDER. IT WAS NOT USED FOR THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON EVALUATION, THE INSERTION DID NOT MEET THE REQUIREMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8108203 ↗