T2 ALPHA 2353-3301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327338638), received between Mar 26, 2020 and Jan 26, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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.

• MalfunctionJan 26, 2022Failure to Align; Device Damaged by Another Device; Failure to Align; Device Damaged by Another Device

  AS REPORTED: "WHEN SETTING NAIL DEPTH VERSION WITH DRILL TIP ICON WIRES WE BACKED THE WIRES....OF FEMORAL NECK ALL NEED, MOVED NAIL/ TARGETER MORE ANTERIOR ON PATIENT TO AIM MORE POSTERIOR FOR OPTIMAL VERSION. THE WIRE THEN MISSED THE NAIL ANTERIOR TO THE NAIL. CAUSED A DELAY IN THE CASE TO EXECUTE CORRECT ROTATION OF NAIL." LENGTH OF THE DELAY WAS NOT PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13361348 ↗
• MalfunctionMar 26, 2020Fracture; Fracture

  AS REPORTED: "23533301 RECON KNOB FEMUR ANTEGRADE BROKE INTO THREE PIECES DURING A PF NAILING. THE NAIL WAS BEING IMPLANTED USING THE MALLET ON THE ASSEMBLED JIG WITH THE STRIKE PLATE ATTACHED. ON ONE BLOW OF THE MALLET A PIECE OF THE KNOB WAS SEEN TO FLY ACROSS THE OPERATING ROOM APPROXIMATELY 2 METRES. IT IS UNCLEAR TO EVERYONE IN THE ROOM IF THE KNOB HAD COME INTO CONTACT WITH A CLAMP THAT WAS DISTAL TO THE JIG".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886646 ↗