STRATAFIX SXPP1A100Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031227736), received between Feb 12, 2018 and May 20, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233050 ↗
• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DOCTOR WAS DOING CABG PROCEDURE, WHEN HE WAS DOING DISTAL ANASTOMOSIS WITH THE HELP OF PROLENE THEN SUTURE GOT BREAKDOWN FROM THE MID POINT... NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233049 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING SURGERY, THE TAB CAME OFF EASILY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800552 ↗
• MalfunctionFeb 3, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE DETACHED IMMEDIATELY. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. 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. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250929 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE FIXATION TAB WAS BROKEN WHEN USING. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605665 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE FIXATION TAB WAS BROKEN DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCE TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276958 ↗
• InjuryJul 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE TIP OF THE NEEDLE WAS BROKEN DURING SURGERY, AND THE TIP OF THE NEEDLE COULD NOT BE FOUND. AN X-RAY WAS TAKEN DURING SURGERY, BUT IT WAS IMPOSSIBLE TO JUDGE WHETHER THE LOCATION OF THE NEEDLE WAS IN THE ABDOMINAL CAVITY OR OUTSIDE, AND THEREFORE THE ABDOMEN WAS CLOSED. WHEN ANOTHER CT SCAN WAS TAKEN ON THE MORNING OF THE (B)(6), THE TIP OF THE NEEDLE 1 - 2 MM WAS OBSERVED. BECAUSE IT IS DIFFICULT TO OPEN THE ABDOMEN AGAIN AND REMOVE THE NEEDLE TIP AND ALSO BECAUSE THERE IS NO CHANGE IN THE PATIENT'S CONDITION AT THIS POINT IN TIME, THE SURGEON IS PLANNING TO EXPLAIN IT TO THE PATIENT AND THE PATIENT WILL BE FOLLOWED UP. FROM THE APPEARANCE, THE TIP OF A NEEDLE WAS BROKEN. THE OTHER NEEDLE APPEARED TO BE BENT FROM THE CENTER OF THE NEEDLE. THE PATIENT COMPLAINED OF PAIN AFTER SURGERY, BUT THE SURGEON THINKS IT IS A COMMON PAIN ASSOCIATED WITH SURGERY. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15026509 ↗
• MalfunctionFeb 22, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577940 ↗
• MalfunctionDec 22, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057122 ↗
• MalfunctionDec 22, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2020 AND A BARBED SUTURE WAS USED. DURING SUTURING ON THE SUBCUTIS, THE NEEDLE WAS DETACHED FROM THE SUTURE AT THE 1ST STITCH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11057117 ↗
• MalfunctionApr 8, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE ON (B)(6) 2020 AND THE BARBED SUTURE WAS USED. AFTER THE CROSS STITCH WAS PLACED ON THE SUBCUTIS AND A SURGEON WAS FIXING THE TAB AND PUTTING ABOUT 3 STITCHES, THE BARBED SUTURE BROKE. THE SURGEON OPINED ABOUT POSSIBLE CAUSE OF THE ISSUE THAT WHILE HE WAS PLACING THE CROSS STITCH, THE NEEDLE MIGHT HAVE TOUCHED THE PORTION OF THE SUTURE WHICH HAD ALREADY BEEN PUT ON/UNDER THE TISSUE, CAUSING DAMAGE ON THE SUTURE. THE SURGERY TIME WAS EXTENDED 30 MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9936512 ↗
• MalfunctionDec 19, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HYSTEROMYOMA/MYOMECTOMY PROCEDURE ON (B)(6) 2019 AND THE BARBED SUTURE WAS USED. IT WAS REPORTED THAT AFTER FINISHING SEWING, THE BARBED SUTURE BROKE SEVERAL TIMES AT THE TIME OF APPLICATION OF BIPOLAR ELECTROCOAGULATION. HOWEVER, THEY DID NOT TOUCH EACH OTHER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9493132 ↗
• MalfunctionDec 17, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2019 AND BARBED SUTURE WAS USED. WHEN THE SURGEON WAS PULLING THE SUTURE WITH THE USUAL FORCE, DURING FIXATION OF THE TAB, THE SUTURE WAS BROKEN. IT WAS FOUND THAT THE FIXATION TAB HAD BEEN BROKEN. THE WHOLE SUTURE ESCAPED FROM THE TISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9477836 ↗
• MalfunctionJul 31, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A JOINT SURGERY ON (B)(6) 2019 AND BARBED SUTURE WAS USED. DURING THE ARTIFICIAL JOINT SURGERY, THE FIXATION TAB OF THE DEVICE WAS BROKEN DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8848224 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN USING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061168 ↗
• MalfunctionNov 12, 2018Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2018 AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE BROKE DURING SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060505 ↗
• MalfunctionFeb 12, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7263081 ↗