T2 1819-1015SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540673374), received between Mar 7, 2019 and Jul 15, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "THE POSTERIOR ANTERIOR SCREW ARRIVED NEXT TO THE NAIL. THE SURGEON WAS ABLE TO REMOVE THE SCREW AND CHOOSE TO NOT PUT IT BACK IN.".

  Patient problems: Insufficient Information

  MAUDE report 22509871 ↗
• InjuryDec 6, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A T2 ANKLE NAIL THAT WAS IMPLANTED A FEW WEEKS PRIOR IS NOW REQUIRING A REVISION SURGERY WITHIN THE NEXT WEEK DUE TO THE NAIL FRACTURING. THE 10X150MM ANKLE NAIL USED FOR FRACTURE, WAS LOCKED WITH 1 PROXIMAL TIBIAL SCREW AND ONE DISTAL CALCANEAL SCREW. STRYKER HAD RECOMMENDED THE USE OF ADDITIONAL LOCKING SCREWS FOR EXTRA STABILITY AND THE ADDITION OF AN END CAP TO LOCK THE CONSTRUCT, HOWEVER STRYKER ADVICE WAS NOT IMPLEMENTED. THE PATIENT WILL BE REVISED WITH REMOVAL OF THE ANKLE NAIL AND FUSION OF THE ANKLE WITH PLATING.

  Patient problems: Failure of Implant

  MAUDE report 15923081 ↗
• MalfunctionMar 7, 2019Failure to Advance

  CUSTOMER REPORTED THAT THE COMPRESSION SCREW WOULD NOT ADVANCE THROUGH THE NAIL.

  Patient problems: No Information

  MAUDE report 8401842 ↗