T2 1806-3305Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540379719), received between Nov 12, 2018 and Apr 21, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (2 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 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.

• MalfunctionApr 21, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT A PROXIMAL TARGETING ADAPTER DID NOT TARGET THE SECOND OF TWO PROXIMAL HOLES. IT WAS OKAY FOR THE HOLE PRIOR. THE SURGEON ELECTED NOT TO IMPLANT A SECOND PROXIMAL SCREW. OPERATIVE SIDE IS LEFT AND THERE WAS APPROXIMATELY A 2 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704191 ↗
• MalfunctionApr 15, 2020Failure to Align; Failure to Align

  THE CUSTOMER REPORTED THAT THE AIMING JIG FOR SHORT LENGTH SUPRACONDYLAR NAILS IS INACCURATE AND AS A CONSEQUENCE MISSING THE NAIL.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9963928 ↗
• MalfunctionNov 12, 2018Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT WHEN THE DISTAL SIDE OF THE PROXIMAL SCREW WAS INSERTED, IT WAS MISSED THE TARGET . THEREFORE, THE SCREW WAS REMOVED AND OPERATION WAS FINISHED. THE DOCTOR'S COMMENT: WHEN DRILLING FOR THE PROXIMAL LATERAL SCREW, SOMETIMES INVOLVED FASCIA, IT MAY BE DUE TO A FAILURE TO DRILL SMOOTHLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8061877 ↗