T2 2339-1320SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327293197), received between Feb 2, 2023 and Jan 6, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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.

• InjuryJan 6, 2026Fracture

  AS REPORTED: "AFTER USING THE SHORT NAIL, AN OBLIQUE FRACTURE WAS OBSERVED FROM THE PROXIMAL END OF THE NAIL TOWARD THE PROXIMAL REGION DURING THE FINAL CONFIRMATION OF THE LATERAL VIEW. THIS LIKELY OCCURRED WHEN THE NAIL WAS DRIVEN IN DURING INSERTION. AS A COUNTERMEASURE, THE SHORT NAIL WAS REMOVED AND A 10 MM/320 MM LONG NAIL WAS INSERTED.".

  Patient problems: Insufficient Information

  MAUDE report 23982575 ↗
• InjuryMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2025. TWO WEEKS AFTER THE PRIMARY SURGERY, TWO DISTAL SCREWS (ALS) BAKED OUT. REVISION SURGERY FOR REINSERTION WAS PERFORMED ON (B)(6) 2025.".

  Patient problems: Insufficient Information

  MAUDE report 21952164 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "UPON TIGHTENING THE END CAP AND FINAL CONFIRMATION WITH X-RAY, A FRACTURE LINE WAS DISCOVERED PROXIMAL TO THE MOST PROXIMAL LOCKING SCREW. THE SURGEON CONSIDERED PRESERVING IT AS IS, BUT BECAUSE OF THE RISK OF RE-FRACTURE, HE REPLACED THE NAIL WITH A LONG NAIL THAT PREPARED AS A BACKUP." ADDITIONALLY IT WAS REPORTED THAT THERE WAS A 45 MINUTE SURGICAL DELAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17072958 ↗
• MalfunctionFeb 2, 2023Device Difficult to Setup or Prepare; Insufficient Device Problem Information; Device Difficult to Setup or Prepare; Insufficient Device Problem Information

  AS REPORTED: "WHILE INSERTING A 32.5MM ADVANCED SCREW INTO THE DISTAL HOLE ON THE PROXIMAL SIDE OF THE 200MM NAIL OF THE T2 ALPHA RETRONAIL, IT GOT STUCK AND THE HEAD FLOATED 8MM AND WAS NOT FIXED BICORTICALLY." THE IMPLANT WAS PLACED AND THE SURGERY WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282411 ↗