T2 ALPHA 2353-3106Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327357066), received between Apr 28, 2023 and Aug 20, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Failure to Align

  As reported: "During insertion of a distal locking screw using the Gamma4 distal targeting device, drilling was performed with a locking drill. While advancing through the medial cortex, an audible sound was noted, and fluoroscopy confirmed that the drill had deviated posterior to the nail.The drill was withdrawn and drilling was reattempted. During the second attempt, a loud sound was heard and the drill stopped within the nail. Fluoroscopic evaluation confirmed that the drill remained within the intended trajectory, and drilling was continued. A subsequent loud sound was heard, and fluoroscopy revealed fracture of the drill approximately 25 mm from the tip while inside the nail.The fractured fragment was retrieved using forceps and a K-wire. The procedure was completed successfully without further complications."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50348319 ↗
• MalfunctionFeb 12, 2026Failure to Align

  AS REPORTED: "DUE TO INSUFFICIENT ADJUSTMENT OF THE ADJUSTING DEVICE, THE MOST DISTAL ADVANCE LOCKING SCREW OF THE TWO DISTAL TRANSVERSE STOPS WAS INSERTED INTO THE BONE WITHOUT PASSING THROUGH THE NAIL. THIS WAS DISCOVERED AFTER WOUND CLOSURE. REINSERTION OF THE SCREW OUTSIDE THE NAIL WAS NOT PERFORMED, AND THE PLAN IS TO OBSERVE THE SITUATION AND TAKE ACTION AS APPROPRIATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24328429 ↗
• MalfunctionJan 9, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "DURING SURGERY OF T2ALPHA-GT RIGHT, THE SLEEVE DID NOT REACH THE BONE WHEN USING THE DISTAL DEVICE. CAUSE UNKNOWN. MAYBE DUE TO PATIENT'S ANATOMY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18473483 ↗
• MalfunctionAug 28, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "DURING T2ALPHA GT SURGERY, THE SLEEVE INSERTED TO THE DISTAL DEVICE DID NOT CONTACT WITH THE BONE. AS A RESULT, THE DEPTH GAUGE MEASUREMENT WAS AMBIGUOUS, AND THE SCREWDRIVER WAS NOT LONG ENOUGH TO INSERT THE SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17637565 ↗
• MalfunctionApr 28, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "A SLEEVE WAS INSERTED USING A DISTAL TARGETING DEVICE, BUT THE SLEEVE DID NOT REACH THE BONE AND COULD NOT BE DRILLED AND MEASURED. THE SCREW WAS INSERTED FREEHAND.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831665 ↗