T2 1823-0015SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540369369), received between Aug 7, 2018 and Aug 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionAug 7, 2018Break; Collapse

  THE PATIENT UNDERWENT T2 TIBIA SURGERY ON (B)(6) 2017, AND THE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2018. WHEN THE END CAP WAS ATTEMPTED TO BE REMOVED WITH A DRIVER BUT THE HEAD OF THE END CAP COLLAPSED. THEREFORE, THE CONICAL EXTRACTOR WAS USED TO REMOVED THE END CAP BUT THE TIP OF THE EXTRACTOR BROKE IN THE HEAD OF THE END CAP, AND THE BROKEN TIP COULD NOT BE REMOVED. THE SURGEON TRIED TO REMOVED THE END CAP BUT IT COMPLETELY STUCK IN THE NAIL, SO ONLY LOCKING SCREWS WERE REMOVED AND THE NAIL REMOVAL SURGERY WAS GAVE UP. BROKEN FRAGMENT REMAINING.

  Patient problems: Foreign Body In Patient

  MAUDE report 7756162 ↗