TC-100 71170033Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010180704), received between Nov 17, 2020 and Jun 5, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TIBIA OSTEOSYNTHESIS PROCEDURE, WHEN LOCKING SCREWS WITH A HEX SCREWDRIVER SHAFT UPON THE SECOND TURN OF THE SCREW, THE HEAD BROKE OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17062136 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT A HEX SCREWDRIVER SHAFT, THE HEAD SNAPPED OFF. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742460 ↗
• InjuryNov 17, 2020Break; Break

  IT WAS REPORTED THAT DURING TREATMENT THE TIP OF THE HEX SCREWDRIVER SHAFT BROKE OFF WHILE PUTTING LOCKING SCREW INTO PLATE. THE BROKEN TIP WAS RETRIEVE AND X-RAY WAS USED TO CONFIRM THAT NOTHING WAS LEFT IN PATIENT. THERE WAS NO REPORTED DELAY. A S&N BACK UP DRIVER IN SET WAS USED TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10850423 ↗