T2 ALPHA 2360-5070SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327368512), received between Nov 20, 2023 and Feb 23, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Fracture

  AS REPORTED: "ON TUESDAY (B)(6) 2025 I RECEIVED A MESSAGE TO COME IN AND SUPPORT A CASE TO REMOVE A BROKEN GAMMA NAIL. THE SURGEON DOING THE REVISION CASE WAS BOOPALAN RAMASAMY. THE PLAN WAS TO REMOVE THE BROKEN NAIL, USE THE SYNTHEES RIA REAMER TO TRY AND PREVENT ANY INFECTION AND THEN RE-FIXATE THE FRACTURE WITH A SMITH AND NEPHEW NAIL. ORIGINAL CASE DATE FOR IMPLANTATION OF THE GAMMA NAIL WAS (B)(6) 2025." 01/27/2026 - UPON PRODUCT RETURN, A BROKEN SCREW WAS IDENTIFIED.

  Patient problems: Insufficient Information

  MAUDE report 24421509 ↗
• InjuryMay 6, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "ANKLE NAIL WAS INTRODUCED. SCREWS WERE LOCKED. MOST DISTAL CALCANEAL SCREW TRAJECTORY WAS DRILLED WITH A 4.2MM DRILL, TROUGH THE TARGETING DEVICE. THE DRILL DIDN'T END UP IN THE HOLE, BUT SCRATCHED THE NAIL ON THE SIDE. THE NAIL WAS REMOVED, TESTED AND RE-INSERTED. THE INCIDENT HAPPENED AGAIN. THIS WAS TRIED 3 TIMES. SURGERY WAS DELAYED BY 2 HOURS. A PLATE WAS USED TO FUSE THE ANKLE, WHICH LEAD TO EXTRA INCISION AND DUE TO THE PLATE NO BONE GRAFT COULD BE USED, WHICH WAS PLANNED."

  Patient problems: Insufficient Information

  MAUDE report 21966994 ↗
• InjuryApr 12, 2024Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED: "PATIENT INTERACTION WITH A COUPLE OF LOCKING SCREWS THAT WERE PLACED IN THE LEFT FEMUR, WHICH HAS PRESENTED AS JUST REALLY SEVERE ITCHING."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19102125 ↗
• InjuryNov 20, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT ROLLED AROUND IN BED AND FELT A POP IN THEIR KNEE. ALL 4 DISTAL INTERLOCKING SCREWS HAVE BROKEN. CASE TOOK LONGER THAN WE WANTED DUE TO BROKEN HARDWARE SO IT ADDED ROUGHLY 45MINS TO AN HOUR ONTO OUR CASE."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 18169564 ↗