STRATAFIX SXPP1A407Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10705031227644), received between Nov 13, 2018 and Aug 5, 2024 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED ON 7/8/2024 AFTER RECEIVING SOME PRODUCT SAMPLES UPON OPENING IT WAS FOUND THAT THERE WAS NO PRODUCT INSERT IN THE BOXES. THE BOXES HAVE QR CODES ON IT BUT IT DOES NOT WORK. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906536 ↗
• MalfunctionAug 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED ON 7/8/2024 AFTER RECEIVING SOME PRODUCT SAMPLES UPON OPENING IT WAS FOUND THAT THERE WAS NO PRODUCT INSERT IN THE BOXES. THE BOXES HAVE QR CODES ON IT BUT IT DOES NOT WORK. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906467 ↗
• MalfunctionAug 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED ON 7/8/2024 AFTER RECEIVING SOME PRODUCT SAMPLES UPON OPENING IT WAS FOUND THAT THERE WAS NO PRODUCT INSERT IN THE BOXES. THE BOXES HAVE QR CODES ON IT BUT IT DOES NOT WORK. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906463 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING CONTINUOUS SUTURING, IN THREE NEEDLES PART OF THE ANCHOR WHICH IS CLOSE TO THE SWAGE PART WAS BROKEN AND FLOWN AWAY. 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 19247099 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING CONTINUOUS SUTURING, IN THREE NEEDLES PART OF THE ANCHOR WHICH IS CLOSE TO THE SWAGE PART WAS BROKEN AND FLOWN AWAY. 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 19247097 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING CONTINUOUS SUTURING, IN THREE NEEDLES PART OF THE ANCHOR WHICH IS CLOSE TO THE SWAGE PART WAS BROKEN AND FLOWN AWAY. 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 19247095 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED ON THE DEEP FASCIA. THREE MONTHS AFTER SURGERY, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF REDNESS AND ITCHING AT THE WOUND SITE. THE PATIENT WAS PRESCRIBED STEROID TAPE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Itching Sensation

  MAUDE report 18851611 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOW PROCEDURE ON AN UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324310 ↗
• MalfunctionAug 30, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324302 ↗
• MalfunctionAug 30, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324297 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOW PROCEDURE ON AN UNKNOWN DATE AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324284 ↗
• MalfunctionAug 30, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324279 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND THE BARBED SUTURE WAS USED. DURING SURGERY, THE TAB BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254815 ↗
• MalfunctionAug 18, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 08/03/2022 AND THE BARBED SUTURE WAS USED. DURING SURGERY, THE TAB BROKE IN HALF. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254723 ↗
• MalfunctionOct 13, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INCISIONAL HERNIA PROCEDURE ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, NEAR THE END OF THE CONTINUOUS SUTURE RUN, THE SURGEON USING THE ¿SHOELACE AFFECT¿, WHILE TIGHTENING THE SUTURE, THE SURGEON PULLED HARD AND THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624866 ↗
• MalfunctionOct 13, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INCISIONAL HERNIA PROCEDURE ON (B)(6) 2021 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, NEAR THE END OF THE CONTINUOUS SUTURE RUN, THE SURGEON USING THE ¿SHOELACE AFFECT¿, WHILE TIGHTENING THE SUTURE, THE SURGEON PULLED HARD AND THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624851 ↗
• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHILE TIGHTENING. ANOTHER DEVICE WAS USED TO CONTINUE THE SURGERY WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014283 ↗
• MalfunctionJun 17, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHILE TIGHTENING. ANOTHER DEVICE WAS USED TO CONTINUE THE SURGERY WITH NO PATIENT CONSEQUENCES. NO ADDITIONAL WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014281 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE REP DURING A VENTRAL HERNIA PROCEDURE AS THE SURGEON PULLED DOWN ON THE SUTURE IT SNAPPED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE FROM A DIFFERENT LOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802409 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE REP DURING A VENTRAL HERNIA PROCEDURE AS THE SURGEON PULLED DOWN ON THE SUTURE IT SNAPPED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE FROM A DIFFERENT LOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802348 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE REP DURING A VENTRAL HERNIA PROCEDURE AS THE SURGEON PULLED DOWN ON THE SUTURE IT SNAPPED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE FROM A DIFFERENT LOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801271 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE REP DURING A VENTRAL HERNIA PROCEDURE AS THE SURGEON PULLED DOWN ON THE SUTURE IT SNAPPED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE FROM A DIFFERENT LOT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801218 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON UNKNOWN DATE IN 2019 AND BARBED SUTURE WAS USED. THE SUTURE WAS USED ON FASCIA AND INTERCOSTAL MUSCLE TOGETHER. ON (B)(6) 2019, THE PATIENT EXPERIENCED BLEEDING. AN ADDITIONAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. THE SURGEON OPINED THAT THE TAB HURT THE SMALL BRANCH OF MUSCLE. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8689212 ↗
• MalfunctionFeb 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAMINECTOMY ON (B)(6) 2019 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS CLOSING THE FASCIA AND THE NEEDLE SEPARATED FROM THE SUTURE ON THE LAST BACK STITCH. THE DOCTOR HAD ENOUGH BACK STITCHES TO SECURE THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8359811 ↗
• MalfunctionFeb 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAMINECTOMY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE SEPARATED FROM THE NEEDLE WHEN REMOVED FROM THE STERILE PACKET. A SECOND LIKE SUTURE PACKET WAS OPENED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON REVIEW OF RETURNED DEVICE, THE SUTURE WAS EXAMINED AND THE INSERTION DID NOT MEET THE REQUIREMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8356090 ↗