RIGIDFIX 213719Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705003105), received between Aug 19, 2018 and Dec 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING DECONTAMINATION, IT WAS OBSERVED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE LOCK SCREW THAT ATTACHES THE RIGIDFIX ROD WITH THE BONE GUIDE WAS FOUND TO BE BROKEN THAT A LITTLE PORTION OF THE SCREW REMAINED INSIDE THE LOCKING POINT; AND THEREFORE THE DEVICES COULD NOT BE SEPARATED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11065253 ↗
• MalfunctionNov 5, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S 1PK AND THE RIGIDFIX FEM ROD, 9.5MM GOT STUCK TOGETHER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10796412 ↗
• MalfunctionAug 19, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT WHEN REMOVING THE RIGIDFIX ST GUIDEFRAME AT THE END OF THE PROCEDURE THE THUMBSCREW BROKE OFF CAUSING THE GUIDEFRAME AND THE 9 1/2 MM FEMORAL ROD TO BECOME STUCK TOGETHER. THE SURGEON HAD COMPLETED THE PROCEDURE WITH THE DEVICE AT THIS POINT. THE SALES REP CONFIRMED THERE WERE PATIENT CONSEQUENCES OR DELAY. THE DEVICES ARE BEING RETURNED FOR EVALUATION. THE SALES REP COULD NOT PROVIDE THE LOT NUMBERS BUT REPORTED THAT THE GUIDEFRAME WAS OVER 5 YEARS OLD AND THE FEMORAL ROD WAS AROUND 9 YEARS OLD AND BOTH HAVE SEEN HEAVY USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7796258 ↗