T2 1806-1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540196521), received between Aug 27, 2019 and Oct 6, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2025Failure to Align; Failure to Align

  AS REPORTED: "THE T2 TIBIAL NAIL WAS MOUNTED ON THE NAIL ADAPTER AT THE TARGET BAR AND INSERTED INTO THE TIBIA. WITH STATIC LOCKING (ON BOTH SIDES), IT WAS NOT POSSIBLE TO REACH THE HOLE IN THE NAIL WITH THE DRILL, RESULTING IN A SMALL DIFFERENCE THAT PREVENTED THE DRILL FROM DRILLING THROUGH THE NAIL HOLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23220013 ↗
• MalfunctionJul 14, 2025Failure to Align; Failure to Align

  AS REPORTED: "T2 TIBIAL AIMING DEVICE HAS PLAY IN THE FIXATION TO THE METAL POST. AIMING WITH SLEEVE AT HOLES IN THE NAIL IMPAIRED." HOW WAS THE ISSUE SOLVED? FREE-HAND-TECHNIQUE WITH CAREFUL USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496748 ↗
• MalfunctionMay 21, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "THE INSTRUMENTS, ONCE THE PATIENT HAD ALREADY BEEN ANESTHETIZED, WERE FOUND TO BE DEFECTIVE AND UNUSABLE. OUR AGENT HAD TO URGENTLY DELIVER ANOTHER INSTRUMENT, WHICH WAS WITHDRAWN IN AN EMERGENCY FROM ONE OF OUR DEPOSIT ACCOUNTS, CAUSING CONSIDERABLE INCONVENIENCE TO BOTH CUSTOMERS AND SIGNIFICANTLY LENGTHENING THE DURATION OF THE OPERATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064403 ↗
• MalfunctionDec 19, 2023Failure to Align; Failure to Align

  AS REPORTED: "MISDRILLINGS OCCURED. THE SURGERY WAS SUCCESSFULLY COMPLETED BY PERFORMING FREEHAND LOCKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357375 ↗
• MalfunctionDec 28, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE DRILL HOLES IN THE T2 TIBIAL TARGETING ARM DIDN'T ALIGN WITH THE SCREW HOLES OF THE NAIL. THIS WAS DISCOVERED WHEN ASSEMBLING THE NAIL ON TO THE TARGETING DEVICE, PRIOR TO ANY PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064216 ↗
• MalfunctionJul 20, 2021Crack; Crack

  IT WAS REPORTED THE TIBIA NAIL DISTAL TARGETING DEVICE HAS BEEN BROKEN WHERE THE TEXT M-L HOLES FOR STANDARD OR DISTAL NAIL ONLY IS FOUND. THIS WAS NOTICED WHEN THE SURGEON WAS PUTTING IN THE SCREWS; IT WAS LACKING A FEW MM TO CORRECTLY HAVE THEM FIT INTO THE NAIL. THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS FOR THE PATIENT BY SETTING SCREWS IN THE NAIL USING ANOTHER SCREW HOLE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196994 ↗
• MalfunctionAug 27, 2019Break; Difficult or Delayed Positioning; Detachment of Device or Device Component; Difficult or Delayed Positioning

  THE CUSTOMER REPORTED THAT THEY PUT THE DRILL THROUGH THE JIG AND INTO THE NAIL AND THAT THE JIG HAD TOO MUCH PLAY IN IT WHICH CAUSED THE DRILL TO SNAP OFF IN THE PATIENT AND NAIL. IT WAS DEEMED TO DIFFICULT TO GET THE PIECE OUT SO THE SURGEON LEFT IT IN SITU. UNINTENDED METAL IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8935581 ↗