STRATAFIX SXMP1B425Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031236578), received between Jul 12, 2018 and Mar 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY PROCEDURE IN 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE REP DURING A SIMPLE PROSTATECTOMY THE SURGEON NOTICED THAT WHEN HE WAS PERFORMING THE ANASTOMOSIS THE BARBED SUTURE IS SUPPOSED TO HOLD TIGHT AFTER PASSING THROUGH TISSUE BUT IT WAS "BACK SLIDING", AND NOT HOLDING TIGHT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584447 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PHARYNGOSTOMY ON (B)(6) 2018 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681060 ↗