RIGIDFIX 213004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705019953), received between Mar 4, 2022 and Mar 6, 2024 — 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 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON AN UNKNOWN DATE THE RIGIDFIX CURVE GUIDE FRAME DEVICE HAD A BROKEN SCREW IN THE CURVE SET. IT WAS IMPOSSIBLE TO USE THE GUIDE WITHOUT THAT SCREW. IN ORDER TO RESOLVE THE ISSUE, THE SURGEON USED A BACK-UP SET. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849552 ↗
• MalfunctionMar 4, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RIGIDFIX CURVE GUIDE FRAME DEVICE BROKE AND BLOCKED INTO THE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666794 ↗