T2 ALPHA 2353-4113Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327358018), received between May 9, 2022 and Feb 16, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionFeb 16, 2024Break; Fracture; Device Difficult to Setup or Prepare; Material Deformation; Break; Fracture; Device Difficult to Setup or Prepare; Material Deformation

  AS REPORTED BY REP: "STRIKE PLATE SNAPPED FROM THE TARGETING ADAPTER WHILE INSERTING THE NAIL (HITTING THE STRIKE PLATE USING THE HAMMER)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727661 ↗
• MalfunctionDec 7, 2023Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "DETECTED METAL CHIPS IN INSERTS FOR T2 ALPHA SPI, AFTER WASHING/CLEANING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283060 ↗
• MalfunctionDec 7, 2023Residue After Decontamination; Material Deformation; Residue After Decontamination; Material Deformation

  AS REPORTED: "DETECTED METAL CHIPS IN INSERTS FOR T2 ALPHA SPI, AFTER WASHING/CLEANING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283059 ↗
• MalfunctionMay 9, 2022Mechanical Jam; Mechanical Jam

  AS REPORTED: "THE SURGEON INSERTED A 9MM T2 ALPHA TIBIA NAIL VIA THE SUPRAPATELLAR APPROACH. SURGEON REAMED TO 10.5, AND MEASURED 320. HE CHOSE TO USE A 300 NAIL. THE CANAL WAS NARROW AND THE SURGEON WOULD HAVE USED AN 8MM NAIL IF AVAILABLE. PROXIMAL SCREWS AND THEN DISTAL SCREWS WERE INSERTED. AFTER DISTAL SCREW INSERTION, SURGEON WAS UNABLE TO DETACH NAIL HOLDING BOLT FROM THE IM ROD. THE SURGEON SPENT 10 MINUTES TRYING TO USE THE BALL TIP SCREW DRIVER TO DISENGAGE THE BOLT. HE WAS UNABLE TO DO SO. VICE GRIPS WERE EVENTUALLY USED TO REMOVE THE SCREW. FORCE AND COUNTER FORCE HAD TO BE USE TO DISENGAGE THE SCREW FROM THE ROD AND REMOVE THE NAIL ADAPTER / NAIL HOLDING BOLT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14340611 ↗