NA 2351-0220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327361742), received between Jan 2, 2024 and Mar 6, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Material Deformation; Material Deformation

  AS REPORTED: "DURING THE T2 ALPHA TIBIA REMOVAL SURGERY, THE END CAP COULD NOT BE REMOVED, AND THE SURGERY WAS FINISHED WITH THE T2 NAIL REMAINING TO THE PATIENT. ALSO TWO SCREWDRIVER TIPS WERE DAMAGED BY THE TORQUE."

  Patient problems: Foreign Body In Patient

  MAUDE report 21536602 ↗
• MalfunctionAug 29, 2024Failure to Align; Failure to Align

  THE SPLITTING RECON LAG SCREW BIT/ROD SET DID NOT LOCK AND MADE THE ENDCAP FILTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20101418 ↗
• MalfunctionAug 13, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  REVISION SURGERY DUE TO NAIL BREAKAGE. THE RECON SCREWDRIVER DID NOT TURN, AND THE END CAP BECAME WORN. THE SURGEON TRIED TO INSERT THE SCREWDRIVER WITHOUT THE ROD, BUT THE TIP OF THE SCREWDRIVER WAS TWISTED AND DEFORMED. ADDITIONAL INFORMATION - THE NAIL DID NOT BREAK. PROXIMAL TIBIAL BONE AROUND NAIL BREAKS.

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975717 ↗
• InjuryFeb 20, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  AS REPORTED: "IN A LOAN OF THE T2 ALPHA, AN IMPORTANT INSTRUMENT WAS NOT IN THE SET. THIS WAS NOT INDICATED BY THE KIT ROOM OR PLANNING AT THE SHORTAGE MAIL. THIS COULD BE CONCLUDED BY THE REPRESENTATIVE ON SITE WHEN THE OPERATION WAS ALREADY IN PROGRESS. AS A RESULT, THE OUTCOME WAS NOT OPTIMAL AND THE PATIENT HAD TO BE OPERATED ON A SECOND TIME IN THE SAME WEEK."

  Patient problems: Insufficient Information

  MAUDE report 18739522 ↗
• MalfunctionJan 2, 2024Break; Fracture; Material Deformation; Material Twisted/Bent; Break; Fracture; Material Deformation; Material Twisted/Bent

  AS REPORTED: "THE HEAD OF THE END CAP SLIPPED DURING REMOVAL, CAUSING REMOVAL DIFFICULTY. THE END CAP WAS LOCKED TIGHTLY AND THE TIP OF THE SCREWDRIVER WAS DEFORMED. THE REVERSE THREADED SCREWDRIVER OF THE REMOVAL INSTRUMENT WAS ALSO BROKEN. OTHER INSTRUMENTS USED WERE ALSO DAMAGED. FINALLY THE END CAP AND OTHER IMPLANTS WERE REMOVED FROM THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18425682 ↗