TC-100 71176032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010302793), received between Sep 22, 2021 and Sep 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• MalfunctionSep 22, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR A THR, IT WAS NOTICED THAT A 3.2 DRILL BIT QC 145/120 HAD PERFORATED THE STERILE PACKAGING, IT IS APPARENT THE BLACK PLASTIC INSERTS HAD DISLODGED FROM THE CLEAR PLASTIC TUBE RESULTING IN THE SHARP TIP OF THE DRILL PERFORATING THE STERILE OUTER PACKAGING. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511111 ↗
• MalfunctionSep 22, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THE SET UP FOR A THR, IT WAS NOTICED THAT A 3.2 DRILL BIT QC 145/120 HAD PERFORATED THE STERILE PACKAGING, IT IS APPARENT THE BLACK PLASTIC INSERTS HAD DISLODGED FROM THE CLEAR PLASTIC TUBE RESULTING IN THE SHARP TIP OF THE DRILL PERFORATING THE STERILE OUTER PACKAGING. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12511110 ↗