NA 2361-5037SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327381702), received between Nov 23, 2021 and Mar 12, 2025 — classified as 3 injuries, 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 18, 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.

• InjuryMar 12, 2025Mechanical Jam; Mechanical Jam

  AS REPORTED: "T2ALPHAGT NAIL SURGERY. THIS WAS PERFORMED ON A PATIENT WITH A METATARSAL AND STARTED WITH THE INSERTION OF A PROXIMAL SCREW. THE PROXIMAL SCREW WAS INSERTED OBLIQUELY AS PLANNED, AND WHILE INSERTING THE ALS INTO THE PROXIMAL TRANSVERSE STATIC HOLE (DISTAL ON THE PROXIMAL SIDE), THE SCREW BECAME STUCK AND NEITHER ADVANCED NOR RETURNED. SURGEON TRIED TO REMOVE THE ALS THAT HAD BECOME STUCK BY COMBINING A SCREWDRIVER BIT LONG (B)(6) AND A SELF-RETAINING SCREWDRIVER SLEEVE LONG (B)(6), BUT IT WAS NOT POSSIBLE". THE (B)(6) NO LONGER ENGAGED WITH THE (B)(6) PROPERLY. THE ALS, WHICH WAS PROTRUDING OUTWARD, WAS CUT WITH AN PIN CUTTER, AND THE SCREW WAS SAFELY CUT. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583335 ↗
• InjuryDec 21, 2022Migration; Migration

  IT WAS REPORTED THAT AN ALS BACKED OUT FROM THE T2 ALPHA TIBIAL NAIL. THE PATIENT HAS A HISTORY OF STROKE AND IS ON DIALYSIS DUE TO DIABETES. THE SUBJECT ADVANCED LOCKING SCREW WAS INSERTED IN THE FOURTH HOLE FROM THE PROXIMAL, BUT THERE WAS ALMOST NO ENGAGEMENT BETWEEN THE SCREW AND CORTICAL BONE DUE TO OVERLAP WITH THE SCREW HOLE POSITION AT THE PRIMARY SURGERY. THE PRIMARY SURGERY WAS PERFORMED WITH ANOTHER COMPANIES' NAIL AND THE REVISION SURGERY WAS PERFORMED WITH T2 ALPHA ON (B)(6) 2022, BECAUSE OF PSEUDARTHROSIS. IN ADDITION, THE PATIENT DID NOT LISTEN TO THE SURGEON'S INSTRUCTIONS ON MOVEMENT RESTRICTIONS, ETC. ONLY THE SCREW THAT BACKED OUT WAS REMOVED ON (B)(6) 2022.

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16020043 ↗
• MalfunctionDec 2, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT WHEN THE ADVANCED LOCKING SCREW WAS INSERTED TO T2 ALPHA GT NAIL, IT GOT STUCK AND COULD BE NEITHER ADVANCED NOR PULLED OUT. ATTEMPTS WERE MADE TO EXTRACT THE SCREW, BUT THE HEAD WAS WORN OUT AND COULD NO LONGER BE EXTRACTED. AS A RESULT, THE HEAD WAS CUT OFF AND THE SURGERY WAS COMPLETED. THIS RESULTED IN EXTENDED OPERATING TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904030 ↗
• InjuryNov 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED: "THE DOCTOR IMPLANTED A T2 ALPHA TIBIA NAIL. AFTER A FEW MONTHS THE ADVANCED LOCKING SCREWS BACKED OUT." THE IMPLANTS WERE EXPLANTED AS A RESULT.

  Patient problems: Failure of Implant

  MAUDE report 12859250 ↗