STRATAFIX SXPP1A302Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031227651), received between Nov 29, 2017 and Jan 15, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN THE NEEDLE-SUTURE WAS HELD AND TRIED TO SUTURE, THE NEEDLE AND THE SUTURE WERE DETACHED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085841 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND SUTURE WAS USED. DURING THE SURGERY, THE FIXATION TAB CAME OFF THE SUTURE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796873 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, TWO FIXATION TABS BROKE IN A ROW DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818584 ↗
• MalfunctionSep 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, TWO FIXATION TABS BROKE IN A ROW DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818579 ↗
• InjurySep 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE WAS BROKEN AND WOUND DEHISCENCE OCCURRED SO RE-SUTURE WAS PERFORMED. THE PATIENT RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15364259 ↗
• InjuryAug 29, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY MEDIAL PARA PATELLAR FASCIORRHAPHY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT HEARD A BUMPING/CRACKLING SOUND DURING REHABILITATION. THEREFORE, THE SURGEON CHECKED THE PATIENT, AND IT WAS FOUND THAT THE WOUND WAS DEHISCED AT SEVERAL POINTS. THEN, RE-SUTURE WAS PERFORMED ON ANOTHER DAY. THE PATIENT HAS NO PROBLEMS. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED AS DISCHARGED FROM THE HOSPITAL. THE PATIENT IS NOW RECOVERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15316370 ↗
• MalfunctionOct 20, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2020; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB CAME OFF THE SUTURE WHEN PULLING AT THE 1ST STITCH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10704806 ↗
• MalfunctionApr 27, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING CONTINUOUS SUTURING ON THE FASCIA. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10001645 ↗
• MalfunctionJan 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN PULLING THE SUTURE DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601691 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING SURGERY, THE FIXATION TAB BROKE. UPON EVALUATION OF THE RETURNED SAMPLE IT WAS FOUND THAT THE TWO SIDES OF THE FIXATION TAB WERE BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8253169 ↗
• MalfunctionNov 29, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OB-GYN PROCEDURE ON (B)(6) 2017 AND BARBED SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM THE SUTURE LIKE A CONTROL RELEASE NEEDLE AT THE THIRD PASSING OF THE NEEDLE THROUGH THE TISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7068534 ↗