INFINITY 33600030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889797004008), received between May 9, 2022 and Oct 18, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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. Mar 6, 2024Open, Classified

   Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide.

   Z-1477-2024 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN USED A SCREWDRIVER TO LOCK IN THE PURPLE SCREW, THE CONNECTION BETWEEN THE PURPLE SCREW AND THE BOTTOM WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625192 ↗
• MalfunctionOct 14, 2022Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam

  THE ADJUSTMENT BLOCK WAS NOT EASY TO TURN THE KNOBS ON, WHEN ADJUSTED WITH SCREWDRIVER THE GREEN KNOBS AXEL BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15611309 ↗
• MalfunctionAug 9, 2022Mechanical Jam; Mechanical Jam

  IT WAS NOTICED THE RESECTION ADJUSTMENT BLOCK WOULDN'T TRANSLATE PROXIMAL DISTAL AT THE END OF THE PROCEDURE. THE PURPLE KNOB IS LOCKED AND WON¿T REALLY TURN WITH SIGNIFICANT FORCE APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195593 ↗
• InjuryMay 9, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A CONVENTIONAL INFINITY TOTAL ANKLE REPLACEMENT WENT THAT WRONG. AFTER INITIAL SIZING AND CHECKING, THE CUTS WERE MADE. THEN THE CUTS LOOKED DIFFERENT FROM WHAT WE SIZED SO WE WENT BACK TO CHECK THE SIZING AGAIN AND THEN THE SIZING WAS COMPLETELY DIFFERENT FROM THE PREVIOUS PICTURES AND THE CUTS WERE TOO WRONG SO WE COULDN¿T PROCEED WITH AN INFINITY PROCEDURE. THE PATIENT WAS CLOSED UP AND A WEEK LATER THEY WENT IN FOR A ANKLE ARTHRODESIS.

  Patient problems: Insufficient Information

  MAUDE report 14337006 ↗