T2 ALPHA 2337-1038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327288704), received between Jun 20, 2019 and Jul 14, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF FEMUR FRACTURES WITH THE FEMORAL NAIL PIRIFORMIS FOSSA (PF) OF THE T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM SUBJECT (B)(6). PATIENT DEVELOPED DEEP VEIN THROMBOSIS ON THE IPSILATERAL SIDE (RIGHT LOWER EXTREMITY) DISTAL TO THE PF NAIL IMPLANT. DOPPLER STUDY ((B)(6) 2023) DAY PRIOR TO 9 MONTH POST-OP FOLLOW-UP VISIT ON (B)(6) SHOWS DVT PERSISTS. ORTHO DEFERRED TREATMENT TO ONCOLOGY DUE TO BREAST CANCER SETTING. PRESCRIPTION FOR 5 MG ELIQUIS STILL CURRENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17325045 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF FEMUR FRACTURES WITH THE FEMORAL NAIL PIRIFORMIS FOSSA (PF) OF THE T2 ALPHA FEMUR ANTEGRADE GT/PF NAILING SYSTEM SUBJECT 03-056. X-RAYS TAKEN AT 6-MO FOLLOW-UP ((B)(6) 2023) : AP/LATERAL VIEWS OF RIGHT FEMUR DEMONSTRATE A WELL ALIGNED AND HEALING FEMORAL SHAFT FRACTURE. THERE MAY BE SOME INCREASED CALLUS FORMATION POSTERIORLY BUT IT DOES NOT APPEAR TO BE UNITED. X-RAYS ON (B)(6) 2023 AT 9-MO POST-OP APPOINTMENT SHOW INCREASED CALLUS BUT NOT BONE CONSOLIDATION. PLAN IS TO MANAGE CONSERVATIVELY AND X-RAY AGAIN AT 12-MONTH APPOINTMENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17309562 ↗
• MalfunctionJun 20, 2019Difficult to Advance

  IT WAS REPORTED THAT, WHILE USING THE T2 ALPHA PF NAIL, THE SURGEON PUT THE NAIL DOWN THE CANAL AND WAS USING THE RECON LOCKING CONSTRUCT AND WENT TO PUT THE INFERIOR WIRE IN USING THE THREADED RECON WIRE AND TRIED TO ADJUST THE TRAJECTORY ANTERIOR AND THE WIRE CONTINUOUSLY MISSED THE NAIL ANTERIOR. BECAUSE THE WIRE WOULD NOT GO THROUGH THE NAIL, THE DOCTOR WAS FORCED TO USE A DIFFERENT LOCKING CONFIGURATION WHICH DELAYED THE CASE. SURGICAL DELAY OF 30 MINUTES WITHOUT ADDITIONAL ANESTHESIA TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8716504 ↗