STRATAFIX SXPP1B112Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10705031235984), received between Dec 7, 2017 and Sep 28, 2026 — classified as 9 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break

  It was reported a patient underwent an unknown surgery on (b)(6) 2026 and barbed suture was used. The suture was broken after passing it through just one stitch when used for wound closure. It was not a control release needle. Another product was used to complete the case. There were no adverse consequences to the patient. Further details are not provided. Additional information has been requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917326 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE NEEDLE AT THE PROXIMAL END WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364372 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112530 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A C-SECTION, DURING DERMIS SUTURING, THE SUTURE WAS BROKEN ALTHOUGH NO EXCESSIVE FORCE APPLIED. THE USE WAS STOPPED, AND ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935045 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A C-SECTION, DURING DERMIS SUTURING, THE SUTURE WAS BROKEN ALTHOUGH NO EXCESSIVE FORCE APPLIED. THE USE WAS STOPPED, AND ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935034 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A C-SECTION, DURING DERMIS SUTURING, THE SUTURE WAS BROKEN ALTHOUGH NO EXCESSIVE FORCE APPLIED. THE USE WAS STOPPED, AND ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934988 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A C-SECTION, DURING DERMIS SUTURING, THE SUTURE WAS BROKEN ALTHOUGH NO EXCESSIVE FORCE APPLIED. THE USE WAS STOPPED, AND ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934950 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, WHEN THE PACKAGE WAS OPENED WHILE DERMAL SUTURING, IT WAS FOUND THAT THE SUTURE HAD BEEN BROKEN. THE PRODUCT WAS NOT USED FOR THE PATIENT. 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 23921170 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN WHEN THE NEEDLE WAS PASSED THROUGH THE TISSUE DURING DERMAL SUTURES. AFTER THAT, THE WOUND WAS CLOSED USING A SINGLE NODULE SUTURE WITH VCPB. THE POSTOPERATIVE COURSE WAS UNEVENTFUL AND THERE WAS NO PROBLEM TO THE PATIENT. THE DOCTOR SAID THAT THERE IS A POSSIBILITY THAT THE SUTURE WAS TWISTING WHILE STITCHING. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE PRODUCT WAS USED ON THE DERMIS. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540859 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN DURING SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383590 ↗
• MalfunctionApr 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING A CESAREAN SECTION, THE SUTURE WAS BROKEN DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866739 ↗
• MalfunctionFeb 21, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN OPEN CARDIOVASCULAR SURGERY, THE SUTURE WAS BROKEN DURING THE WOUND CLOSURE. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432823 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UNKNOWN OPEN OB-GYN SURGERY, THE SUTURE WAS BROKEN DURING DERMAL SUTURE. A NEW SUTURE WAS TAKEN OUT AND THE WOUND CLOSURE COULD BE DONE WITHOUT ANY PROBLEM. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313953 ↗
• MalfunctionOct 3, 2024Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358119 ↗
• MalfunctionJun 4, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY: TKA PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PRODUCT WAS USED ON THE DERMIS DURING CONTINUOUS SUTURING. IT HAD NOT GET CAUGHT IN THE TISSUE WHEN PASSING IT THROUGH THE LOOP. AFTERWARDS, ANOTHER NEW PACKAGE WAS OPENED, IT COULD USE WITHOUT PROBLEM. THE OPERATION TIME WAS NOT EXTENSION. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457413 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6)2024; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE SUTURING THE FASCIA. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19099627 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GASTRECTOMY PROCEDURE ON (B)(6) 2024, AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING CONTINUOUS SUTURE ON THE DERMIS. ANOTHER PACKAGE WAS USED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887269 ↗
• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN THE NEEDLE WAS PULLED, THE NEEDLE WAS BROKEN AT SWAGE PART. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502088 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN THE FIRST STITCH WAS APPLIED ON DERMIS, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18404117 ↗
• MalfunctionDec 4, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18261317 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING USE ON DERMIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546513 ↗
• MalfunctionAug 10, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS FOUND THAT THE LOOP WAS BROKEN. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE, THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. MARKS ON THE BODY NEEDLE APPEAR TO BE BY USE OF SURGICAL INSTRUMENT COULD BE OBSERVED. THE SUTURE WAS EXAMINED, BODY FLUIDS WERE NOTED. IN ADDITION, IT WAS OBSERVED THAT THE WELD OF FIRST LOOP WAS DETACHED NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498618 ↗
• MalfunctionAug 1, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS BROKEN. THERE WAS NO CONSEQUENCE TO THE PATIENT AND THE PATIENT IS FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439419 ↗
• InjuryJul 21, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RESPIRATORY SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGERY WAS A SINGLE HOLE CASE, AND THE PRODUCT WAS USED LIKE A DRAWSTRING SUTURE AGAINST THE DRAIN HOLE. THE DRAIN TUBE WAS REMOVED SEVERAL DAYS AFTER THE SURGERY. DURING REMOVAL, THE PRODUCT AND THE PRECLEAN DRAIN INTERFERED WITH EACH OTHER, CAUSING THE TUBE TO SPLIT. ONE SIDE OF THE DIVIDED TUBE REMAINED IN THE THORACIC CAVITY. ON X-RAY EXAMINATION THE NEXT DAY, THE REMAINING TUBE WAS NOTICED, AND THE PATIENT UNDERWENT THE RE-OPERATION TO REMOVE THE REMAINING DRAIN TUBE FROM THE BODY. THE PATIENT¿S CONDITION IS NOW STABLE AND WELL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE SURGEON OPINES THAT THERE IS A CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND THE EVENT. [SURGEON¿S COMMENT] ¿I FULLY UNDERSTOOD AND USED THE PRODUCT CHARACTERISTICS, AND WHILE I COULD EXPECT SOME INTERFERENCE WITH THE DRAIN, I DID NOT THINK IT WAS ENOUGH TO CAUSE A BREAKAGE. SINCE THERE WAS NO DEFECT IN THE SUTURE, THERE WAS NO DIRECT FAULT.¿ [OTHER CONTRIBUTING FACTOR] IN ADDITION TO THE EXISTING SIDE HOLES ON THE DRAIN TUBE PRECLEANER, A NURSE CREATED ADDITIONAL SIDE HOLES USING A SHEAR KNIFE

  Patient problems: Foreign Body In Patient

  MAUDE report 17371990 ↗
• InjuryJun 16, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED WITH CONTINUOUS SUTURE. AFTER THE SURGERY, WHEN THE PATIENT'S WOUND WAS CHECKED IN THE WARD, THE DERMAL SUTURE WAS BROKEN AND WOUND DEHISCENCE OCCURRED. IN THE WARD, THE DERMIS WAS RE-SUTURED WITH ONE OR TWO STITCHES. NO FURTHER TREATMENT PLAN. THE SURGEON RE-STITCHED IT AND IT HEALED FINE. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17142375 ↗