STRATAFIX SXPP1A402Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031218741), received between Feb 12, 2019 and Oct 20, 2023 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON AN UNKNOWN DATE IN 2023 AND BARBED SUTURE WAS USED. THE THREAD BROKE WHILE SEWING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974769 ↗
• MalfunctionOct 31, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC COLECTOMY PROCEDURE (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB WAS BROKEN DURING USE. DETAILS ARE FOLLOWING. AFTER THE NEEDLE WAS PASSED THROUGH THE TISSUE AND HANGING THE FIXATION TAB ON THE WOUND, WHEN THE SURGEON TRIED TO PUT THE 2ND STITCH, A JOINT PART BETWEEN THE FIXATION TAB AND THE SUTURE DETACHED. THERE WAS NO TENSION THAT SHOULD NORMALLY OCCUR WHEN THE FIXATION TAB WAS APPLIED TO THE WOUND, AND IT DETACHED EASILY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705373 ↗
• MalfunctionAug 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC COLORECTAL CANCER SURGERY PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAB WAS BROKEN DURING CONTINUOUS SUTURING. AFTER THE NEEDLE WAS PASSED THROUGH THE FASCIA AND HANGING THE FIXATION TAB ON THE WOUND, WHEN A SURGEON TRIED TO PUT THE 2ND STITCH, A JOINT PART BETWEEN THE FIXATION TAB AND THE SUTURE DETACHED. THERE WAS NO TENSION THAT SHOULD NORMALLY OCCUR WHEN THE FIXATION TAB WAS APPLIED TO THE WOUND, AND IT DETACHED EASILY. A DEMONSTRATION MACHINE WAS USED TO DEMONSTRATE THE TENSILE STRENGTH DURING SUTURE PULLING. THE SURGEON DEMONSTRATED WITH A NEEDLE HOLDER. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271743 ↗
• MalfunctionJun 30, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP BOWEL RESECTION ON (B)(6) 2022 AND SUTURE WAS USED. THE FIXATION TAP WAS DIVIDED BEFORE IT CAME OUT FROM THE PACKAGE. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880376 ↗
• MalfunctionApr 28, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, END TAB OF SUTURE WAS DEFECTIVE AND UNABLE TO USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246209 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE THE FIXATION TAB WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT OCCURRED BEFORE USE OR DURING USE. AS FOR THE ACTUAL PRODUCT, IT IS IN PRETTY CLEAN CONDITION, SO IT IS POSSIBLE THAT THE ISSUE WAS FOUND AFTER THE PACKAGE WAS OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13536795 ↗
• InjuryDec 13, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP SURGERY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED TO CLOSE THE FASCIA. POST-OP, THE SUTURE DID NOT HOLD IN TISSUE AND RESULTED IN WOUND DEHISCENCE AND INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 12983097 ↗
• MalfunctionNov 11, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE CLOSURE OF THE FASCIAL LAYER OF TISSUE, THE SUTURE BEGAN TO DETHREAD FROM THE NEEDLE AND THEN THE NEEDLE POPPED OFF. A SECOND LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305708 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, THE FIXATION TAB HAD CHIPPED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198373 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, THE FIXATION TAB HAD CHIPPED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198369 ↗
• InjurySep 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON (B)(6) 2019 AND SUTURE WAS USED. POST-OPERATIVELY, THE SEATING TAB CAME LOOSE AND THE DEVICE UNRAVELED. THIS CAUSED A WOUND DEHISCENCE. THE PATIENT WAS RE-OPERATED ON (B)(6) 2019 TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 9130503 ↗
• InjurySep 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON (B)(6) 2019 AND BARBED SUTURE WAS USED. POST OPERATIVELY, THE SEATING TAB CAME LOOSE AND THE DEVICE UNRAVELED. THIS CAUSED A WOUND DEHISCENCE. THE PATIENT WAS RE-OPERATED ON (B)(6) 2019 TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 9130395 ↗
• MalfunctionJun 4, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION PROCEDURE ON (B)(6) 2019 AND BARBED SUTURE WAS USED. DURING 1ST PASSING OF THE NEEDLE THROUGH THE ABDOMINAL WALL MUSCLE LAYER BY CONTINUOUS SUTURING, THE FIXATION TAB OF THE BARBED SUTURE WAS BROKEN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8668402 ↗
• MalfunctionMay 10, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2019 AND BARBED SUTURE WAS USED. THE STAFF REPORTED THAT THE SUTURE DID NOT HAVE A FIXATION TAB ATTACHED FROM THE BEGINNING. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON EVALUATION, NO DEFECTS OR DAMAGED ON THE BARBS WERE NOTED. HOWEVER, THE TWO SIDES OF THE FIXATION TAB WERE BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600356 ↗
• MalfunctionMar 13, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR WAS SUTURING THE FASCIA LAYER TISSUE IN A CONTINUOUS LOOP AND THE NEEDLE BROKE OFF AT THE SWAGE. THE NEEDLE AND SUTURE WERE REMOVED FROM THE PATIENT AND A SECOND LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417377 ↗
• MalfunctionFeb 12, 2019Break; Break

  IT WAS REPORTED THAT A SIGMOID COLON RESECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATIVELY, MAYBE FIVE DAYS LATER, THE SUTURE HAD COMPLETELY BROKEN. THE PATIENT IS DOING FINE POST FOLLOWUP SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332575 ↗