STRATAFIX SXMP1B109Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031236608), received between Apr 27, 2018 and Feb 18, 2026 — classified as 5 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A PLASTIC SURGERY PROCEDURE THAT THE NEEDLE REPEATEDLY POPPED OFF THE SUTURE THREAD DURING USE. THIS HAPPENED 3-4TIMES DURING THE PROCEDURE. ANOTHER BOX OF SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381085 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A PLASTIC SURGERY PROCEDURE THAT THE NEEDLE REPEATEDLY POPPED OFF THE SUTURE THREAD DURING USE. THIS HAPPENED 3-4TIMES DURING THE PROCEDURE. ANOTHER BOX OF SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381084 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A PLASTIC SURGERY PROCEDURE THAT THE NEEDLE REPEATEDLY POPPED OFF THE SUTURE THREAD DURING USE. THIS HAPPENED 3-4TIMES DURING THE PROCEDURE. ANOTHER BOX OF SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381083 ↗
• MalfunctionFeb 18, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A PLASTIC SURGERY PROCEDURE THAT THE NEEDLE REPEATEDLY POPPED OFF THE SUTURE THREAD DURING USE. THIS HAPPENED 3-4 TIMES DURING THE PROCEDURE. ANOTHER BOX OF SUTURE WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381081 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRATAFIX BROKE INTRA-OP WHILE SURGEON FLEXED THE KNEE AFTER CLOSING THE INCISION. THE HCP SAID THAT IT BROKE PROXIMALLY AND THEN DISTALLY. THEY HAD TO RECLOSE THE INCISION WITH STAPLES. THERE WAS A 5-MINUTE DELAY BUT THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR ANY OTHER ISSUES. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464847 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRATAFIX BROKE INTRA-OP WHILE SURGEON FLEXED THE KNEE AFTER CLOSING THE INCISION. THE HCP SAID THAT IT BROKE PROXIMALLY AND THEN DISTALLY. THEY HAD TO RECLOSE THE INCISION WITH STAPLES. THERE WAS A 5-MINUTE DELAY BUT THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR ANY OTHER ISSUES. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464844 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2023, AND BARBED SUTURE WAS USED. THE BARBED SUTURE BROKE INTRA-OP WHILE SURGEON FLEXED THE KNEE AFTER CLOSING THE INCISION. THE HEALTH CARE PROFESSIONAL SAID THAT IT BROKE PROXIMALLY AND THEN DISTALLY. THEY HAD TO RECLOSE THE INCISION WITH STAPLES. THERE WAS A 5-MINUTE DELAY BUT THE CASE WAS COMPLETE WITH NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460148 ↗
• MalfunctionJan 4, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE INTRA-OP WHILE SURGEON FLEXED THE KNEE AFTER CLOSING THE INCISION. THE HCP SAID THAT IT BROKE PROXIMALLY AND THEN DISTALLY. THE INCISION WAS RECLOSED WITH STAPLES. THERE WAS A 5 MINUTE DELAY BUT THE CASE WAS COMPLETED WITHOUT PATIENT HARM OR ANY OTHER ISSUES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 18444983 ↗
• MalfunctionJan 20, 2023Dull, Blunt; Dull, Blunt

  IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT A NEEDLE BREAKAGE OCCURRED, A FRACTURE WAS OBSERVED AT THE TIP OF THE NEEDLE. IT WAS REPORTED BY THE CUSTOMER THAT DURING GYN PROCEDURE ON (B)(6) 2022, DURING SUBCUTICULAR CLOSURE THE NEEDLE WAS NOTED TO BE BLUNT BY SURGEON. SURGICAL TECH INSPECTED NEEDLE AND COMPARED TO A NEW NEEDLE. WAS IMMEDIATELY SEQUESTERED AND PACKAGING SET ASIDE. THE SURGERY WAS DELAYED BY TWO MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218531 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. ON (B)(6) 2022, WOUND DEHISCENCE OCCURRED WHICH REQUIRED THE PATIENT TO RETURN TO SURGERY. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15436916 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROTOMY ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE ON THE PATIENT WHEN USED TO CLOSE SKIN USING SUBCUTICULAR STITCH. AFTER A FEW PASSES , THE NEEDLE BROKE INTO 2. SURGEON USED MONOCRYL 3/0 TO CONTINUE TO CLOSE SKIN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15365878 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. POST-OP, THE PATIENT CAME BACK WITH AN INFECTION. ANTIBIOTICS WERE USED TO TREAT THE PATIENT. THE PATIENT IS NOW OKAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 15232457 ↗
• MalfunctionMay 6, 2022Positioning Failure; Positioning Failure

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310610 ↗
• 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 14286585 ↗
• 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 14283736 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND THE BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP CAME UNDONE AS THE SUTURE STRAND BROKE. ANOTHER LIKE SUTURE WAS USED TO RE-START SUTURING AND COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805054 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RESECTION PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING THE SUTURING OF LAPAROSCOPIC PORT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11644626 ↗
• InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HAND SURGERY PROCEDURE ON UNKNOWN DATE (B)(6) 2018 AND BARBED SUTURE WAS USED. ONE WEEK POST PROCEDURE, THE SCAR WAS HEALED AND PATIENT EXPERIENCED ERYTHEMATOUS AND SEROUS DISCHARGE. THE SURGEON NOTED THE AREA TAKES THREE WEEKS TO SUBSIDE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Purulent Discharge

  MAUDE report 7700184 ↗
• InjuryJul 17, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE FOR TRAUMA ON UNKNOWN DATE (B)(6) 2018 AND BARBED SUTURE WAS USED. ONE WEEK POST PROCEDURE, THE PATIENT EXPERIENCED ERYTHEMATOUS CONDITION AND REDNESS. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE PATIENT IS REPORTED AS HEALED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema

  MAUDE report 7696176 ↗
• InjuryApr 27, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. APPROXIMATELY 4-6 WEEKS POST OPERATIVELY THE PATIENT HAD A BIG FALL AND THE PATIENT'S WOUND DEHISCED. THE PATIENT RETURNED FOR RECLOSURE OF THE WOUND. IT WAS POSSIBLE THAT THE BARBED SUTURE WAS BROKEN IN THE MIDDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7470736 ↗