T2 1822-0003SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540197542), received between Dec 6, 2019 and Nov 8, 2024 — classified as 2 injuries, 2 malfunctions.

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.

• MalfunctionNov 8, 2024Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  AS REPORTED: "WHEN ATTEMPTING TO PLACE THE STANDARD PLUG OF THE T2 TIBIA NAIL THROUGH THE FRAME, THE SPECIALIST REPORTS THAT IT DOES NOT FIT. AFTER REMOVING THE FRAME, THE PLUG STILL DOES NOT SCREW IN. ANOTHER IMPLANT IS THEN USED, AND THIS ONE FITS CORRECTLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646275 ↗
• InjuryDec 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "POSTOPERATIVE LOOSENING OF THE END CAP OCCURRED IN A CASE OF RETROGRADE INSERTION OF A T2 FEMORAL NAIL." ADDITIONAL INFORMATION RECEIVED: REVISION SURGERY WAS PERFORMED DUE TO THE NON-UNION ONE AND A HALF YEARS AFTER THE INITIAL SURGERY. THE LOOSENED END CAP WAS DISCOVERED DURING PATIENT FOLLOW-UP (X-RAYS) AND WAS ALSO REMOVED AT THE TIME OF REVISION ON A HALF YEARS AFTER THE INITIAL SURGERY.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12976304 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, ALLERGIC REACTION, SKIN REDNESS 10 WEEKS POST SURGERY.

  Patient problems: Irritation; Reaction

  MAUDE report 9527266 ↗
• MalfunctionDec 6, 2019Material Deformation; Material Deformation

  AS REPORTED: "IT HAS BEEN REPORTED BY THE CUSTOMER THAT, UPON PLACING THE END CAP (REF.(B)(4)), IT DIDN'T FIT PROPERLY AND WHEN IT WAS REMOVED, IT WAS OBSERVED THAT THE THREADS WERE DAMAGED. IT WAS ATTEMPTED TO PLACE A SECOND TAP (REF. (B)(4)) AND THE SAME THING HAPPENED. SO FINALLY NO CAP WAS PLACED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9434436 ↗