TC-100 71176021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010302748), received between Jan 14, 2019 and Jan 14, 2019 — classified as 1 death.

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 16, 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.

• DeathJan 14, 2019Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A SURGERY WAS PERFORMED ON (B)(6) 2018 OF A COMPETITOR DEVICE(DEPUY LEFT TOTAL HIP) AND THE X-RAY SHOWED WHAT THE SURGEON BELIEVED TO BE A DRILL BIT TIP INTO THE PATIENT'S HIP/FEMUR. SURGEON COMPLETED AN INCIDENT REPORT; HOWEVER THIS WAS TOO LATE FOR THE HOSPITAL TO CAPTURE THE OTHER REMAINING PIECE OF THE DRILL AS IT WAS DISPOSED OF AFTER SURGERY DUE TO IT BEING SINGLE USE. FROM THE REPORT COMPLETED BY THE SURGEON, THE DRILL BIT WAS UNLIKELY TO CAUSE HARM AND UNLIKELY TO MIGRATE, AND HE WAS HAPPY TO HAVE PERIODIC X-RAYS WITH THE PATIENT TO ENSURE THAT THE PIECE WAS NOT CAUSING ANY HARM. THE PATIENT DIED ON THE (B)(6) 2018 AND THE CAUSE OF DEATH HAS NOT BEEN GIVEN. THE HOSPITAL HAS JUST REPORTED THE INCIDENT TO US ON 17/12/2018. THE DOCTOR DOES NOT FEEL THAT THE RETAINED FRAGMENT CAUSED OR CONTRIBUTED TO THIS DEAD. STILL AWAITING FOR THE CORONIAL REPORT TO DETERMINATE IF THIS WAS A DEVICE RELATED ISSUE.

  Patient problems: Death

  MAUDE report 8244636 ↗