STRATAFIX SXMP1B106Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031236684), received between Oct 9, 2018 and Mar 12, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE TIP HAD BROKEN OFF DURING USE. THERE WAS A DELAY IN CLOSURE. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21587673 ↗
• MalfunctionJul 20, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR SPINAL FUSION PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE ADJUSTABLE LOOP/SUTURE STRAND END OF THE STRATAFIX SPIRAL WAS FOUND TO BE BROKEN DURING SKIN CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068079 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR MICRO-DISCECTOMY, FORAMINOTOMY, NEUROLYSIS, L5/S1 BILATERAL PROCEDURE ON (B)(6) 2020 AND BARBED SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT RETURNED TO THE OPERATING THEATRE ON (B)(6) 2020. IT WAS REPORTED THERE WERE NO VISUAL SIGNS OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 9923300 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LUMBAR DISCECTOMY, LAMINECTOMY, FORAMINOTOMY, NEUROLYSIS L3/4 AND L4/5 ON (B)(6) 2020 AND BARBED SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT RETURNED TO THE OPERATING THEATRE ON (B)(6) 2020. IT WAS REPORTED THERE WAS NO INFECTION PRESENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 9921347 ↗
• MalfunctionOct 9, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DR WAS BUSY CLOSING SKIN WHEN SUTURE SNAP. HE USED ANOTHER SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7949199 ↗