STRATAFIX SXPP1B404Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031236073), received between Jul 20, 2020 and Oct 27, 2025 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT NEEDLE POPPED OFF INTO PATIENT ABDOMEN. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS REPORTED. DEVICE WAS NOT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23396722 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A DOCTOR IN THE GYN SPACE SAMPLES TO USE FOR THEIR HYSTERECTOMIES. THEY USED STFX AND THE SAMPLES SNAPPED IN THREE CASES IN ONE DAY, AS THE SURGEON WAS SUTURING ROBOTICALLY. THEY LET REP KNOW THAT THE SAMPLES HAD SNAPPED, AND REP WAS ABLE TO GET MATERIALS TO ORDER THE SUTURE CODE. WHEN THE EVENT OCCURRED, THEY TRIED TO USE ANOTHER SAMPLE AND THEN USED A COMPETITOR. THIS HAS NEVER HAPPENED TO THE SURGEON WHEN USING THE SUTURE IN THE PAST; HOWEVER THIS EVENT OCCURRED WHEN THEY USED SAMPLES REP ORDERED THROUGH GS ONE-STOP. NO PATIENT CONSEQUENCES WAS REPORTED. THERE WAS NO SURGICAL DELAY. DEVICE WAS NOT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437199 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A DOCTOR IN THE GYN SPACE SAMPLES TO USE FOR THEIR HYSTERECTOMIES. THEY USED STFX AND THE SAMPLES SNAPPED IN THREE CASES IN ONE DAY, AS THE SURGEON WAS SUTURING ROBOTICALLY. THEY LET REP KNOW THAT THE SAMPLES HAD SNAPPED, AND REP WAS ABLE TO GET MATERIALS TO ORDER THE SUTURE CODE. WHEN THE EVENT OCCURRED, THEY TRIED TO USE ANOTHER SAMPLE AND THEN USED A COMPETITOR. THIS HAS NEVER HAPPENED TO THE SURGEON WHEN USING THE SUTURE IN THE PAST; HOWEVER THIS EVENT OCCURRED WHEN THEY USED SAMPLES REP ORDERED THROUGH GS ONE-STOP. NO PATIENT CONSEQUENCES WAS REPORTED. THERE WAS NO SURGICAL DELAY. DEVICE WAS NOT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437183 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A DOCTOR IN THE GYN SPACE SAMPLES TO USE FOR THEIR HYSTERECTOMIES. THEY USED STFX AND THE SAMPLES SNAPPED IN THREE CASES IN ONE DAY, AS THE SURGEON WAS SUTURING ROBOTICALLY. THEY LET REP KNOW THAT THE SAMPLES HAD SNAPPED, AND REP WAS ABLE TO GET MATERIALS TO ORDER THE SUTURE CODE. WHEN THE EVENT OCCURRED, THEY TRIED TO USE ANOTHER SAMPLE AND THEN USED A COMPETITOR. THIS HAS NEVER HAPPENED TO THE SURGEON WHEN USING THE SUTURE IN THE PAST; HOWEVER THIS EVENT OCCURRED WHEN THEY USED SAMPLES REP ORDERED THROUGH GS ONE-STOP. NO PATIENT CONSEQUENCES WAS REPORTED. THERE WAS NO SURGICAL DELAY. DEVICE WAS NOT RETURNING. NO ADDITIONAL INFORMATION WAS REQUESTED. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437180 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL CUFF. AFTER SEVERAL PASSES THE SUTURE BROKE. SURGICAL DELAY UNKNOWN. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862146 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL CUFF. AFTER SEVERAL PASSES THE SUTURE BROKE. SURGICAL DELAY UNKNOWN. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861313 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THEY ATTEMPTED TO USE THREE NO CHARGE SAMPLES. THE FIRST ONE, THE NEEDLE POPPED OFF RIGHT OUT OF PACKAGE GOING INTO NEEDLE HOLDER. SECOND ONE BROKE WHEN CLOSING VAGINAL CUSP. THIRD BROKE WHEN USING BOVIE TO MAINTAIN HEMOSTASIS AND IT WAS AROUND THE AREA OF THE SUTURE, NOT ON THE SUTURE ITSELF. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821474 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THEY ATTEMPTED TO USE THREE NO CHARGE SAMPLES. THE FIRST ONE, THE NEEDLE POPPED OFF RIGHT OUT OF PACKAGE GOING INTO NEEDLE HOLDER. SECOND ONE BROKE WHEN CLOSING VAGINAL CUSP. THIRD BROKE WHEN USING BOVIE TO MAINTAIN HEMOSTASIS AND IT WAS AROUND THE AREA OF THE SUTURE, NOT ON THE SUTURE ITSELF. NO PATIENT HARM. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821142 ↗
• MalfunctionJun 12, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND BARBED SUTURE WAS USED. WHEN OPENING THE SUTURE IT BROKE AND FELL APART. ANOTHER LIKE DEVICE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518899 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL PERITONEUM PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BROKE SEVERAL TIMES AND GOT CURLED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587010 ↗
• MalfunctionJan 26, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL PERITONEUM PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BROKE SEVERAL TIMES AND GOT CURLED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587009 ↗
• MalfunctionJan 26, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL PERITONEUM PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BROKE SEVERAL TIMES AND GOT CURLED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587005 ↗
• MalfunctionJan 26, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL PERITONEUM PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURES BROKE SEVERAL TIMES AND GOT CURLED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586989 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON AN UNKNOWN DATE IN 2022 AND BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD NECROTIC WOUND. SEVERE NECROSIS WAS FIRST NOTICED 5 DAYS POST OP. A SKIN FLAP WAS DONE, HEALTHY TISSUE WAS HARVESTED FROM ANOTHER PART OF THE BODY AND PLACED WHERE THE DEAD TISSUE WAS REMOVED. CURRENT PATIENT STATUS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis

  MAUDE report 16216975 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON AN UNKNOWN DATE IN 2022 AND BARBED SUTURE WAS USED. POST-OP, THE PATIENT HAD NECROTIC WOUND. CURRENT PATIENT STATUS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis

  MAUDE report 16216914 ↗
• MalfunctionJan 19, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON SAID HE HAD A PATIENT THAT HE USED A BARBED SUTURE FOR THE CUFF CLOSURE AND THAT POST-OP THE SUTURE CAME LOOSE. THE PATIENT IS DOING WELL. THE SURGEON COULD NOT RECALL THE EXACT CONFIGURATION, BUT BELIEVED IT TO BE A SIZE 0 WITH EITHER A CT-1 OR V-34 NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210153 ↗
• MalfunctionJul 20, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTERECTOMY FOUR MONTHS AGO AND THE BARBED SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT MENTIONED SHE FELT SOMETHING IN HER VAGINA. A PIECE OF SUTURE WAS NOT ABSORBED AND LOOSE IN THE VAGINA, AND ABOUT THREE CM OF PERCEIVED BARBED SUTURE WAS CUT DURING POST-OP EXAMINATION ON JULY 8. IT WAS ALSO REPORTED THAT IT IS UNCERTAIN IF THE PATIENT REMOVED A LOOSE SUTURE PIECE AS IT WAS UN-INTACT, OR THE SURGEON DID IN THE OFFICE THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10300049 ↗