T2 ALPHA 2360-5045SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327366211), received between Sep 7, 2022 and May 24, 2023 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionMay 24, 2023Difficult to Remove; Difficult to Remove

  ONE ITEM BROKE DURING THE SURGERY, MALE EXTRACTOR 4MM. THE ITEM SNAPPED DURING USE, REMOVING A SCREW. FROM MY KNOWLEDGE THE ITEM WAS BEING USED CORRECTLY. THE OPERATION WAS TO REMOVE A T2 ALPHA NAIL IMPLANTED IN FRANCE OVER 2 YEARS AGO. IT IS UNCLEAR IF ANY DEBRIS WAS LEFT IN THE PATIENT. ADDITIONALLY: THE RETURNED LOCKING SCREW DOES SHOW THAT THE REMOVAL OF THE SCREW WAS FINALLY SUCCESSFUL. THE ONLY CONSEQUENCE WE ARE AWARE OF IS THE 40 MINUTES DELAY THAT WAS CAUSED BY THE BREAKAGE OF THE EXTRACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997851 ↗
• InjurySep 7, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PATIENT WAS 3-MONTHS STATUS POST ANTEGRADE NAILING OF A LEFT PROXIMAL FEMORAL SUBTROCHANTERIC FRACTURE. THE PATIENT HAD A SCREW DISENGAGEMENT OF BOTH OF THE DISTAL INTERLOCKS WITH PAINFUL HARDWARE. THIS RESULTED IN THE DEVICE BEING REMOVED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15369544 ↗