T2 ALPHA 2337-1136SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327288940), received between Sep 15, 2020 and Dec 16, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "A SECONDARY FRACTURE OCCURRED IN A PATIENT TREATED 3 YEARS EARLIER, WITH NAIL FRACTURE. (EVENT #1) REVISION SURGERY TO REMOVE THE BROKEN NAIL AND REINSERT A NEW T2ALPHAPF WAS PERFORMED. WHEN DRILLING TO THE MOST DISTAL ROUND HOLE IN THE PROXIMAL PART, THE DRILL WAS GUIDED BY THE PREVIOUS SCREW HOLE AND THE DRILL WAS CONTACTED WITH THE NAIL. THEREFORE, DRILLING WAS PERFORMED WITH THE DRILL SLEEVE HELD MANUALLY. AFTER THAT THE BORE DRILLING WAS PERFORMED AND AN ADVANCED LOCKING SCREW WAS INSERTED TO THE NAIL".

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 20947615 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM (B)(6), IN USA. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE TREATMENT OF FEMORAL FRACTURES WITH THE FEMORAL NAIL PIRIFORMIS FOSSA (PF) OF THE T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM¿. THIS STUDY INCLUDES RESEARCH DONE ON 18 PATIENTS (19 CASES) REQUIRING SURGERY BETWEEN THE PERIOD MARCH 2019 AND OCTOBER 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PAIN. THE REPORT STATES: ¿PATIENT WAS (B)(6) YEARS OLD MALE, HIS BMI IS 31.6, HE WAS A PREVIOUS SMOKER, WITH HISTORY OF DIABETES AND DRUG ABUSE. HIS INJURY WAS DUE TO A MOTOR VEHICLE ACCIDENT AND WAS CLASSIFIED AS 32-B2, CLOSED TYPE. THE DEVICE USED IN THE INITIAL SURGERY WAS 11X360 T2 ALPHA FEMORAL NAIL PF, RIGHT, WITH A PROXIMAL RECON LOCKING MODE. THE PAIN IS SHARP 3.5 MONTHS POST OP, LOCATED A

  Patient problems: Implant Pain

  MAUDE report 10538576 ↗