T2 ALPHA 2341-1024SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327290721), received between Dec 10, 2024 and Dec 10, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Difficult to Remove; Difficult to Remove

  AS REPORTED: DURING NAIL REMOVAL SURGERY, AFTER END CAP REMOVAL, THE ADVANCED LOCKING SCREW WHICH WAS INSERTED TO THE SECOND HOLE FROM PROXIMAL END OF THE NAIL WAS PULLED OUT WITH A SCREWDRIVER, AND WHEN ABOUT 5 MM WAS PULLED OUT, IT STARTED SPINNING AND COULD NOT BE PULLED OUT ANY FURTHER. ONLY THIS SCREW WAS INSERTED PROXIMAL TO THE NAIL. AFTER THAT, THE SURGEON ATTACHED A SELF-RETAINING SCREWDRIVER SLEEVE TO THE SCREWDRIVER, GRIPPED THE SCREW HEAD, AND PULLED IT WHILE TURNING THE SCREWDRIVER, BUT IT KEPT SPINNING. AFTER SPENDING ABOUT 15 MINUTES, THE SCREW COULD NOT BE PULLED OUT, SO THE SURGEON GAVE UP THE REMOVAL OF THE SCREW AND THE NAIL. THE SELF-RETAINING SCREWDRIVER SLEEVE ATTACHED TO THE SCREW HEAD WAS ATTACHED QUITE RIGIDLY, AND HE TRIED TO TURN IT TO REMOVE IT BUT HAD A HARD TIME BECAUSE HE COULD NOT TRANSMIT FORCE PROPERLY. 10 MINUTES WERE SPENT TO REMOVE THE SCREWDRIVER FROM THE SCREW HEAD, ONLY THE DISTAL SCREWS WERE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 20898310 ↗