STRATAFIX SXPP1A419Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031245259), received between Jun 14, 2019 and Mar 8, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA PROCEDURE ON AN UNKNOWN DATE IN 2023 AND BARBED SUTURE WAS USED. WHEN CLOSING THE DEFECT, THE DEVICE BROKE AND LOOKED SHREDDED ON THE END. THE DOCTOR CUT THE FIXATION TAB OFF TO PULL THE USED PORTION OF THE SUTURE THROUGH AND IT BROKE AND SHREDDED AGAIN. THE SURGEON MOVED TO A SIZE 0 VLOC TO COMPLETE THE REPAIR. THERE WAS NO PATIENT CONSEQUENCE. IT CAUSED A FIVE TO TEN MINUTE DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504204 ↗
• MalfunctionJun 25, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, 2/3 OF THE NEEDLE COMPLETELY BROKE IN HALF WHILE CLOSING. SURGEON WAS ABLE TO REMOVE NEEDLE FROM PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. FRAGMENTS WERE GENERATED AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194826 ↗
• MalfunctionSep 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND BARBED SUTURE WAS USED. THE NEEDLE BROKE IN HALF WHILE PASSING THROUGH TISSUE. THE NEEDLE WAS RETRIEVED FROM THE PATIENT AND ANOTHER LIKE DEVICE WAS USED. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135519 ↗
• MalfunctionSep 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND BARBED SUTURE WAS USED. THE NEEDLE BROKE IN HALF WHILE PASSING THROUGH TISSUE. THE NEEDLE WAS RETRIEVED FROM THE PATIENT AND ANOTHER LIKE DEVICE WAS USED. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135496 ↗
• MalfunctionSep 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND BARBED SUTURE WAS USED. THE NEEDLE BROKE IN HALF WHILE PASSING THROUGH TISSUE. THE NEEDLE WAS RETRIEVED FROM THE PATIENT AND ANOTHER LIKE DEVICE WAS USED. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135471 ↗
• MalfunctionSep 30, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2019 AND BARBED SUTURE WAS USED. THE NEEDLE BROKE IN HALF AFTER THE THIRD PASS, WHILE PASSING THROUGH TISSUE. THE NEEDLE WAS RETRIEVED FROM THE PATIENT AND ANOTHER LIKE DEVICE WAS USED. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135466 ↗
• MalfunctionJun 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ROBOTIC HERNIA REPAIR ON (B)(6) 2019 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE SEPARATED FROM THE NEEDLE. IT IS UNKNOWN WHETHER A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE, WHICH WAS DONE SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8731321 ↗
• MalfunctionJun 14, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAP HERNIOGRAPHY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED AT THE SWAGE POINT FROM THE NEEDLE. THE SURGERY WAS DELAYED FIVE MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8701668 ↗