STRATAFIX SXPP1B423Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031235946), received between Jan 21, 2020 and Jan 21, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2020Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TOO EASY WHEN USING. THE SUTURE DID NOT HAVE BARBS THAT ARE STRONG ENOUGH TO HOLD THE TISSUE TOGETHER SO THE SURGEON HAD TO PULL HARDER TO APPROXIMATE THE TISSUE. EVENTUALLY IT BROKE WHEN PULLED ON IT LONG ENOUGH. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612901 ↗
• MalfunctionJan 21, 2020Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TOO EASY WHEN USING. THE SUTURE DID NOT HAVE BARBS THAT ARE STRONG ENOUGH TO HOLD THE TISSUE TOGETHER SO THE SURGEON HAD TO PULL HARDER TO APPROXIMATE THE TISSUE. EVENTUALLY IT BROKE WHEN PULLED ON IT LONG ENOUGH. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612900 ↗
• MalfunctionJan 21, 2020Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TOO EASY WHEN USING. THE SUTURE DID NOT HAVE BARBS THAT ARE STRONG ENOUGH TO HOLD THE TISSUE TOGETHER SO THE SURGEON HAD TO PULL HARDER TO APPROXIMATE THE TISSUE. EVENTUALLY IT BROKE WHEN PULLED ON IT LONG ENOUGH. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612898 ↗
• MalfunctionJan 21, 2020Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TOO EASY WHEN USING. THE SUTURE DID NOT HAVE BARBS THAT ARE STRONG ENOUGH TO HOLD THE TISSUE TOGETHER SO THE SURGEON HAD TO PULL HARDER TO APPROXIMATE THE TISSUE. EVENTUALLY IT BROKE WHEN PULLED ON IT LONG ENOUGH. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612897 ↗
• MalfunctionJan 21, 2020Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE TOO EASY WHEN USING. THE SUTURE DID NOT HAVE BARBS THAT ARE STRONG ENOUGH TO HOLD THE TISSUE TOGETHER SO THE SURGEON HAD TO PULL HARDER TO APPROXIMATE THE TISSUE. EVENTUALLY IT BROKE WHEN PULLED ON IT LONG ENOUGH. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9612892 ↗