T2 ALPHA 2353-4103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327357059), received between Sep 3, 2019 and Oct 5, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionOct 5, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  AS REPORTED: "RIGHT TIBIA T2 ORIF. AFTER ASSEMBLING THE NAIL ADAPTER TIBIA AND THE TARGETING ARM TIBIA, THE SCREW WAS INSERTED. AFTER THAT, I TRIED TO REMOVE IT, BUT IT COULD NOT BE REMOVED." DELAY OF 4-5 MINUTES. "AT THE TIME OF THE EVENT, THE PROXIMAL SCREW HAD BEEN INSERTED, SO IT WAS REMOVED FROM THE NAIL AND THE DISTAL SCREW WAS INSERTED (RADIOLUCENT DRILL)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10632002 ↗
• MalfunctionSep 3, 2019Device Dislodged or Dislocated

  AS REPORTED: "DURING AN INTREMEDULLARY NAIL CASE, THE STRIKE PLATE WAS STRIPPED OUT OF THE NAIL ADAPTER COMPLETELY WHILE ATTEMPTING TO BACKSLAP A NAIL OUT. A SECOND STRIKE PLATE WAS THEN USED IN ORDER TO RE-INSERT THE NAIL AND THIS STRIKE PLATE ALSO FAILED. NEITHER THE NAIL ADAPTER OR STRIKE PLATES WERE VIABLE AND WE HAD TO RESORT TO USING THE OLDER T2 SYSTEM. THIS DELAYED THE CASE AND ALSO ENDED UP IN WASTING THE FIRST NAIL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8958120 ↗