STRATAFIX SXMP1B108Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031236646), received between Nov 1, 2019 and Aug 24, 2026 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Material Separation

  It was reported that a patient underwent a Total Knee Arthroplasty on (b)(6) 2026 and barbed suture was used. It was reported that orthopedic surgeon at this account was finishing a total knee arthroplasty. Surgeon approximated the skin-subcuticular layer with Stratafix Monocryl. The first suture he used, the needle popped off, and the second suture he used, the suture pulled through the fixation loop when he buried the first stitch. To clarify, the fixation loop seemed to break open when pulled taught. First time he has seen this happen. No delay or patient consequences was reported. No additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50407400 ↗
• MalfunctionAug 24, 2026Break

  It was reported that a patient underwent a Total Knee Arthroplasty on (b)(4) 2026 and barbed suture was used. It was reported that orthopedic surgeon at this account was finishing a total knee arthroplasty. Surgeon approximated the skin-subcuticular layer with Stratafix Monocryl. The first suture he used, the needle popped off, and the second suture he used, the suture pulled through the fixation loop when he buried the first stitch. To clarify, the fixation loop seemed to break open when pulled taught. First time he has seen this happen. No delay or patient consequences was reported. No additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50407398 ↗
• InjuryOct 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR PLATE REMOVAL AND SCAR REVERSION FROM A LEFT PROXIMAL HUMERUS FRACTURE SURGERY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, AT THE TIME OF CLOSING THE INCISION, THE PHYSICIAN ASSISTANT (PA) NOTICED THAT THE TIP OF THE NEEDLE WAS MISSING. FROM X-RAY, THE RADIOLOGIST SAW A 1.3MM TIP OF THE NEEDLE IN THE LATERAL SOFT TISSUE OF THE PROXIMAL ARM. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM TO GET THE NEEDLE TIP REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23346932 ↗
• InjuryAug 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SURGEON FELT THAT THE BARBS DID NOT PRONOUNCE AS MUCH AS OTHER SUTURES UTILIZED BEFORE OF THE SAME CODE. THE PATIENT HAD A WOUND DEHISCENCE AND WAS RE-SUTURED WITH A DIFFERENT SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22789173 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. TIP OF THE BARBED SUTURE BROKE OFF DURING SURGEON¿S CLOSURE OF SKIN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22416989 ↗
• InjuryAug 15, 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 ARTHROPLASTY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. FOUND WOUND DEHISCENCE IN SUBCUTICULAR LAYER AFTER 1 MONTH WHEN PATIENT CAME TO PHYSICAL THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17553218 ↗
• InjuryAug 15, 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 ARTHROPLASTY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. FOUND WOUND DEHISCENCE IN SUBCUTICULAR LAYER AFTER 1 MONTH WHEN PATIENT CAME TO PHYSICAL THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17553138 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TARSAL TUNNEL PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. ABOUT FOUR DAYS AFTER THE PROCEDURE, THE WOUND TO OPEN UP AND THE BARBED SUTURE TORE THE SKIN IN THE PROCESS. IT WAS REPORTED THAT THE PATIENT IS OKAY AND CAME BACK INTO THE CLINIC WITH THE SAME SURGEON. THE SURGEON REAPPROXIMATED THE WOUND WITH BARBED SUTURE AND PROVIDED MORE IN-DEPTH WOUND CARE EDUCATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15485407 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED FOR SOFT TISSUE CLOSURE. THE PATIENT HAS HAD PROTRACTED SWELLING AROUND THE OPERATION SITE AND DISTALLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 15473712 ↗
• MalfunctionNov 1, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PACKAGING INTERIOR FOIL WAS RIPPED UP AND AFFECTED STERILITY. THE PRODUCT WAS NOT USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265628 ↗
• MalfunctionNov 1, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PACKAGING INTERIOR FOIL WAS RIPPED UP AND AFFECTED STERILITY. THE PRODUCT WAS NOT USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265624 ↗
• MalfunctionNov 1, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PACKAGING INTERIOR FOIL WAS RIPPED UP AND AFFECTED STERILITY. THE PRODUCT WAS NOT USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265623 ↗
• MalfunctionNov 1, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PACKAGING INTERIOR FOIL WAS RIPPED UP AND AFFECTED STERILITY. THE PRODUCT WAS NOT USED. THERE WERE NO PATIENT CONSEQUENCES REPORTED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265622 ↗