INFINITY 33600025Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889797003971), received between Jan 26, 2023 and Jan 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. 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.

• MalfunctionJan 26, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT " THE PROCEDURE FOR THE PLACEMENT OF THE ANKLE PROSTHESIS WAS STANDARD UNTIL WE WANTED TO PUT THE PIN SLEEVES IN THE HOLES OF THE DISTAL PART OF THE ALIGNMENT JIG. IMPOSSIBLE TO PUT THE 2 SLEEVES IN 2 HOLES OF THE GUIDE. EVEN LESS POSSIBLE TO PUT 2 SOCKETS IN THE AXIS AS REQUIRED BY THE OPERATING TECHNIQUE. WE HAVE TRIED EVERYTHING TO AVOID THE HANDLING ERROR, WITHOUT SUCCESS. WE TRIED TO FIND A SOLUTION TO ADAPT, BUT FOUND NO ALTERNATIVE TO CONTINUE THE PROCEDURE. THE EVENT WAS DISCOVERED DURING THE PLACEMENT OF THE SLEEVES IN THE ALIGNMENT JIG HOLES AS MENTIONED ABOVE. STEPS/ACTIONS TAKEN TO COMPLETE THE PROCEDURE: THE SURGEON MADE THE DECISION TO PERFORM AN ANKLE PLATE ARTHRODESIS. THE DURATION OF THE PROCEDURE WAS THEREFORE LONGER THAN A CONVENTIONAL PLATE ARTHRODESIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247782 ↗
• MalfunctionJan 26, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT " THE PROCEDURE FOR THE PLACEMENT OF THE ANKLE PROSTHESIS WAS STANDARD UNTIL WE WANTED TO PUT THE PIN SLEEVES IN THE HOLES OF THE DISTAL PART OF THE ALIGNMENT JIG. IMPOSSIBLE TO PUT THE 2 SLEEVES IN 2 HOLES OF THE GUIDE. EVEN LESS POSSIBLE TO PUT 2 SOCKETS IN THE AXIS AS REQUIRED BY THE OPERATING TECHNIQUE. WE HAVE TRIED EVERYTHING TO AVOID THE HANDLING ERROR, WITHOUT SUCCESS. WE TRIED TO FIND A SOLUTION TO ADAPT, BUT FOUND NO ALTERNATIVE TO CONTINUE THE PROCEDURE. THE EVENT WAS DISCOVERED DURING THE PLACEMENT OF THE SLEEVES IN THE ALIGNMENT JIG HOLES AS MENTIONED ABOVE. STEPS/ACTIONS TAKEN TO COMPLETE THE PROCEDURE: THE SURGEON MADE THE DECISION TO PERFORM AN ANKLE PLATE ARTHRODESIS. THE DURATION OF THE PROCEDURE WAS THEREFORE LONGER THAN A CONVENTIONAL PLATE ARTHRODESIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247663 ↗