INFINITY 33600020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00889797003926), received between Mar 28, 2023 and Jun 14, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 13, 2023Open, Classified

   The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

   Z-2105-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE GUIDE WAS NOT OPERABLE DURING THE SURGERY. THE SLEEVES DID NOT PASS THROUGH THE HOLES IN THE GUIDE. ALSO, A NUT CAME OFF WHEN THE OPERATOR TRIED TO TURN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17126526 ↗
• MalfunctionMay 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE SLEEVE DID NOT PASS THROUGH THE GUIDE ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981185 ↗
• MalfunctionMay 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE SLEEVE DID NOT PASS THROUGH THE GUIDE ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979899 ↗
• MalfunctionMay 22, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PINS DO NOT FIT INTO THE MATING PARTS OF A DISTAL ALIGNMENT FRAME. THE PIN IS TO SPEC BUT THE FRAME HAS INCONSISTENT SIZES OF HOLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979896 ↗
• MalfunctionMay 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE SLEEVE DID NOT PASS THROUGH THE GUIDE ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979891 ↗
• MalfunctionMay 22, 2023Defective Device; Defective Device

  THE HOLES IN THE GUIDE ARM WERE TO SMALL TO PROPERLY ACCOMMODATE PIN SLEEVES. THE PIN SLEEVES NEEDED TO BE HAMMERED IN AND, AFTER THE PROCEDURE, HAMMERED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979872 ↗
• MalfunctionMay 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PIN COULD NOT BE INSERTED INTO THE CENTER HOLD OF THE ALIGNMENT FRAME GUIDE. MEDICAL PROCEDURE WAS COMPLETED BY PUSHING PIN SLEEVE TO END OF HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979857 ↗
• MalfunctionMay 22, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE SLEEVE DID NOT PASS THROUGH THE GUIDE ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979594 ↗
• InjuryMar 28, 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 16631680 ↗