T2 1822-0934SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540197788), received between Apr 4, 2019 and Jan 18, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 18, 2021Fracture; Fracture

  THE SALES REP REPORTED THAT : "POSE THE NAIL ON AN ALCOHOLIC PATIENT, VERY AGITATED (IN DT), 110KG. RETURN TO HIS ROOM, VERY DISTURBED, MOVES AROUND A LOT, FALLS FROM HIS HEIGHT. NAIL FRACTURE ABOVE THE DISTAL HOLES. REOPERATION ON (B)(6) 2020 FOR REMOVAL OF THE BROKEN MATERIAL AND INSTALLATION OF AN EXTERNAL FIXATOR BECAUSE OF OPEN FRACTURE."

  Patient problems: Failure of Implant; Fall; Limb Fracture

  MAUDE report 11189770 ↗
• MalfunctionApr 4, 2019Activation, Positioning or Separation Problem; Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A TIBIAL NAIL PROCEDURE, WHEN IT CAME TIME TO ATTACH THE NAIL TO THE HOLDING BOLT, THE THREADS INSIDE THE NAIL WOULD NOT ENGAGE WITH THE HOLDING BOLT. MULTIPLE ATTEMPTS WITH NO SUCCESS. A SECOND NAIL WAS OPENED AND THE NAIL SUCCESSFULLY ENGAGED WITH THE HOLDING BOLT. TWO MINUTE SURGICAL DELAY REPORTED. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483110 ↗