TC-100 71170149Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010181404), received between Apr 28, 2022 and Apr 28, 2022 — classified as 1 injury.

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

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.

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.

• InjuryApr 28, 2022Break; Break

  IT WAS REPORTED THAT, WHEN SURGEON COMMENCED DRILLING DURING A TKA SURGERY, THE DRILL BIT LONG 4.5MM QC BROKE. INCIDENT OCCURRED INSIDE PATIENT, AND THE BROKEN PIECE WAS RETRIEVED. SURGERY WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED BEYOND THE ISSUE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246862 ↗