STRATAFIX SXPP1A101Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10705031227743), received between Mar 5, 2018 and Aug 20, 2026 — classified as 3 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50348573 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060080 ↗
• MalfunctionJan 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059734 ↗
• MalfunctionJan 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057104 ↗
• MalfunctionJan 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY DURING USE ON THE PATIENT. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056957 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2025 AND BARBED SUTURE WAS USED ON THE DERMIS. THE WOUND WHERE THE SUTURES HAD BEEN PERFORMED WAS OPENED A LITTLE A FEW DAYS AFTER THE SURGERY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE PATIENT IS BEING FOLLOWED UP. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 21971743 ↗
• MalfunctionDec 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING A TOTAL KNEE ARTHROPLASTY: TKA, WHEN THE SUTURE WHICH WAS USED FOR THE SUBCUTANEOUS OF THE KNEE WAS USED AS A FIXED SUTURING, THE SUTURE (THE BASE OF THE TAB) WAS BROKEN. THE STRENGTH OF THE TRACTION AND OTHER DETAILS ARE UNKNOWN. 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 20864163 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, A SUTURE BREAKAGE OCCURRED ON (B)(6). THE DOCTOR SAID THAT THE SUTURE PART NEAR THE FIXATION TAB AND NEAR THE NEEDLE BROKE AND NOT USED IMPROPERLY, SUCH AS STRONG TRACTION. 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 20749967 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING A TOTAL KNEE ARTHROPLASTY: TKA, ON BOTH (B)(6), WHEN IT WAS FIXED AND SUTURED BY THE SUTURE USED ON THE SUBCUTANEOUS OF THE KNEE, THE SUTURE (OR THE BASE OF THE FIXATION TAB) WAS BROKEN. THE STRENGTH OF THE TRACTION ETC. IS UNKNOWN. 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 20749962 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING A TOTAL KNEE ARTHROPLASTY: TKA, ON BOTH (B)(6), WHEN IT WAS FIXED AND SUTURED BY THE SUTURE USED ON THE SUBCUTANEOUS OF THE KNEE, THE SUTURE (OR THE BASE OF THE FIXATION TAB) WAS BROKEN. THE STRENGTH OF THE TRACTION ETC. IS UNKNOWN. 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 20749958 ↗
• MalfunctionJul 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC SURGERY ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CAME OFF FROM THE NEEDLE WITH USE. IT WAS 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 19822013 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TKA: TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN AROUND THE SWAGE PART DURING CONTINUOUS SUTURING ON SUBCUTANEOUS TISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835205 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. A CROSS STITCH WAS BROKEN DURING USE. THE PRODUCT WAS USED ON SUBCUTANEOUS DERMIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159926 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, AND BARBED SUTURE WAS USED. THE SUTURE BROKE 1~2MM BEFORE THE FIXATION TAB DURING CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654791 ↗
• MalfunctionMar 8, 2023Break; 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, WHEN PUTTING THE FIRST CROSS STITCH ON FASCIA, THE FIXATION TAB WAS BROKEN. ANOTHER SUTURE WAS USED TO CLOSE THE WOUND. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501650 ↗
• InjuryNov 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022 AND A BARBED SUTURE WAS USED FOR SUBCUTANEOUS DERMAL SUTURE. POST-OP, TWO MONTHS LATER, THE PATIENT EXPERIENCED A SYMPTOM THAT SEEMED TO BE A FOREIGN SUBSTANCE REACTION. THE WOUND BECAME WHITE AND DEHISCENT. THE SUTURE BROKE AND DEHISCENCE OCCURRED. THEREFORE, REMOVAL OF THE SUTURE AND EPIDERMAL RE-SUTURING WAS PERFORMED WITH NYLON. THE AREA WHERE THE SUTURE WAS REMOVED WAS RECOVERING. THE PATIENT IS BEING FOLLOWED UP ON AN OUTPATIENT BASIS AND IS DOING WELL. IT WAS OPINED THAT SINCE THE SYMPTOMS IMPROVED AFTER REMOVAL, THERE IS A POSSIBILITY THAT THE DEVICE WAS THE CAUSE OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction; Wound Dehiscence

  MAUDE report 15734093 ↗
• InjuryNov 4, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL TOTAL KNEE ARTHROPLASTY ON (B)(6) 2022 AND A BARBED SUTURE WAS USED FOR SUBCUTANEOUS DERMAL SUTURE. POST-OP, TWO MONTHS LATER, THE PATIENT EXPERIENCED A SYMPTOM THAT SEEMED TO BE A FOREIGN SUBSTANCE REACTION. THE WOUND BECAME WHITE AND DEHISCENT. THE SUTURE BROKE AND DEHISCENCE OCCURRED. THEREFORE, REMOVAL OF THE SUTURE AND EPIDERMAL RE-SUTURING WAS PERFORMED WITH NYLON. THE AREA WHERE THE SUTURE WAS REMOVED WAS RECOVERING. THE PATIENT IS BEING FOLLOWED UP ON AN OUTPATIENT BASIS AND IS DOING WELL. IT WAS OPINED THAT SINCE THE SYMPTOMS IMPROVED AFTER REMOVAL, THERE IS A POSSIBILITY THAT THE DEVICE WAS THE CAUSE OF THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction; Wound Dehiscence

  MAUDE report 15732716 ↗
• MalfunctionJul 25, 2022Material Separation; Material Separation

  IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING SUTURING. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. 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. AFFILIATE REFERENCE NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15100425 ↗
• MalfunctionMay 5, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BREAKAGE OCCURRED DURING CONTINUOUS SUTURING OF SUBCUTANEOUS AND DERMAL TISSUES TOGETHER. THE SUTURE WAS BROKEN AT THE END OF SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14287054 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE CONNECTION PART BETWEEN THE SUTURE AND THE NEEDLE BROKE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760628 ↗
• MalfunctionJun 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE USE ON THE SUBCUTIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007662 ↗
• MalfunctionJun 16, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE USE ON THE SUBCUTIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12007658 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT SUTURE BREAKAGE OCCURRED 2 TIMES IN A ROW DURING CONTINUOUS SUTURING ON THE SUBCUTIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641806 ↗
• MalfunctionApr 9, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT SUTURE BREAKAGE OCCURRED 2 TIMES IN A ROW DURING CONTINUOUS SUTURING ON THE SUBCUTIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11641804 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, TWO (2) SUTURES BROKE IN A ROW DURING WOUND CLOSURE THOUGH THEY WERE USED WITH THE USUAL WAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11509660 ↗