NA 218.065Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982155962), received between Jul 5, 2022 and Jul 5, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TFNA PROCEDURE ON (B)(6) 2022, WHEN THE BLADE WAS INSERTED INTO THE NAIL IT BECAME STUCK HALFWAY. STAFF INDICATED THAT THE SET SCREW WAS HALF DEPLOYED INSIDE OF THE NAIL BEFORE THE NAIL WAS OPENED. THE NAIL WAS REMOVED AFTER 2 HOURS OF SURGERY, THE PATIENT REQUIRED BLOOD. THE DEFECTIVE IMPLANT WAS REMOVED, AND A NEW NAIL AND BLADE WERE INSERTED. THERE WAS A SURGICAL DELAY OF 120 MINUTES, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A 6.5MM CANCELLOUS BONE SCREW FULLY THREADED/65MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14915589 ↗