T2 ALPHA 2337-1140SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327289015), received between Apr 24, 2020 and Apr 24, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2020Difficult to Insert; Difficult to Insert

  AS REPORTED: "PATIENT WAS (B)(6) YEARS OLD MALE, BMI 24.2, NO SIGNIFICANT MEDICAL HISTORY AND NON-SMOKER. THE INJURY WAS DUE TO MOTOR VEHICLE ACCIDENT, RIGHT FEMUR SHAFT FRACTURE CLASSIFIED AS 32-A3, CLOSED TYPE. DURING SURGERY, THE RIGHT FEMUR WAS REAMMED 2 MM OVER AND THE NAIL WAS IMPOSSIBLE TO BE APPLIED. THERE WAS A FRACTURE IN THE DISTAL FEMUR AFTER MULTIPLE TRIES. THE FEMUR 11X*400 T2 ALPHA FEMORAL NAIL PF WAS REMOVED AND A REGULAR T2 NAIL WAS APPLIED WITH THE SAME DIMENSIONS WITH NO COMPLICATIONS. PATIENT HAD PULMONARY EMBOLISM THE DAY OF SURGERY AND WAS DISCHARGED 4 DAYS AFTER SURGERY WITH NO COMPLICATIONS. HE IS 149 DAYS AFTER SURGERY WITH A FRACTURE THAT IS HEALED ABOUT 5 MONTHS POSTOPERATIVELY." ADDITIONALLY REPORTED BY REP: "DUE TO THE TYPE OF FRACTURE PATIENT SUSTAINED THE 11X*400 T2 ALPHA FEMORAL NAIL PF COULD NOT BE INSERTED THEREFORE THE SURGEON DECIDED TO REMOVE IT AND INSTALL REGULAR T2. THE T2 ALPHA NAIL DID NOT CREATE OR CONTRIBUTED TO ANY ADDITIONAL INTRA OPERATIVE FRACTURES." REP ALSO INDICATED THAT THE SURGEON USED REAMERS FROM ZIMMER.

  Patient problems: Pulmonary Embolism

  MAUDE report 9998524 ↗