TC-100 71170036Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010180728), received between Jun 16, 2020 and Sep 16, 2020 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS TRYING TO TIGHTEN UP A SCREW AND THE HEX SCREWDRIVER GOT BROKEN APART. A LOOSE PIECE FELL TO THE GROUND AND WAS RECOVERED. NO DELAY NOR INJURY WAS REPORTED. A S&N BACKUP DEVICE WAS AVAILABLE DURING SURGERY.

  Patient problems: No Patient Involvement

  MAUDE report 10540362 ↗
• InjuryJun 16, 2020Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  IT WAS REPORTED THAT DURING A SURGICAL CASE THE SCREWDRIVER DID NOT ENGAGE THE SCREW DURING INSERTION BECAUSE THE TIP WAS WORN. AFTER THAT, IT WAS SWITCHED SCREWDRIVER SHAFTS, BUT THE OTHER WAS NOT MUCH BETTER, AND BECAUSE THE DOCTOR HAD TO APPLY MORE FORCE THE SCREWDRIVER HEAD SHEERED OFF INSIDE THE PATIENT, BUT ALL PIECES WERE RECOVERED. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE, BUT IT WAS WORN (IT WAS USED). THERE WAS A 5 MIN DELAY WHILE IT BROUGHT THE OTHER HEX SCREWDRIVER. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10160464 ↗