T2 2353-3903Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327381832), received between Jul 17, 2024 and Jul 17, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2024Degraded; Device Difficult to Setup or Prepare; Degraded; Device Difficult to Setup or Prepare

  AS REPORTED: "THE NAIL ADAPTER 2353-3903 MUST BE DAMAGED. IT WOULD NOT ALLOW THE NAIL TO BE THREADED ON TO THE ASSEMBLY WITH THE HOLDING SCREW 2353-3904. THERE WAS NO REPLACEMENT SO THE SURGEON IMPLANTED THE NAIL AND HAD TO ¿FREE HAND¿ THE DISTAL SCREWS. WE TRIED BOTH NAIL HOLDING SCREWS BUT THEY WEREN'T ABLE TO START THREADING IN TO THE NAIL DUE TO THE NAIL ADAPTER. THERE IS NO VISIBLE DAMAGE TO THE HOLDING SCREW THREADS OR ANY OTHER PART OF THE SCREW. THERE MAY BE DAMAGE TO THE NAIL ADAPTER WHERE IT CONNECT TO THE NAIL BUT I DON'T HAVE A SECOND ONE TO COMPARE IT TO. THE SURGEON ENDED UP BYPASSING THE NAIL ADAPTER AND TARGETING JIG AND USED THE "FREEHAND" TECHNIQUE TO DRILL AND INSERT THE TWO DISTAL SCREWS. HE WAS SATISFIED WITH THE RESULTS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760673 ↗