INSTRUMENT I-K3834CG6RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327328592), received between Dec 11, 2020 and Dec 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier.

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 18, 2026.

Recalls naming this device

1. Mar 5, 2021Class IITerminated

   The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.

   Z-1379-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT CUSTOM INSTRUMENTS WERE BEING USED FOR THE FIRST TIME IN A SURGERY FOR A REVISION OF A FAILED TOTAL KNEE REPLACEMENT FOR THE RIGHT KNEE. IT WAS REPORTED THAT THE TRIAL WAS IMPACTED USING THE FEMORAL IMPACTOR WITH TWO LIGHT MALLET BLOWS AND ON THE SECOND IMPACTION, THE LATERAL POSTERIOR CONDYLE OF THE TRIAL IMPLANT FRACTURED AT THE LOCATION OF THE AUGMENT CUT SLOT. THE DAMAGE TO THE TRIAL WAS NOTICED IMMEDIATELY, AND IT WAS REMOVED FROM THE FEMORAL CANAL, AND FEMORAL PREPARATION WAS COMPLETED USING THE STANDARD INSTRUMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10992516 ↗