NA 03.010.499Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982069160), received between Oct 10, 2018 and Oct 10, 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 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.

• MalfunctionOct 10, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE RETROGRADE FEMORAL NAIL INSERTION PROCEDURE, THE DRIVING CAP BROKE OFF FROM THE INSERTION HANDLE AND THE CONNECTION SCREW IS DIFFICULT TO TURN THAT IT SEEMED CROSSED THREADED. THERE WAS NO SURGICAL DELAY AND NO REPORT OF FRAGMENTS. THE ISSUE HAPPENED OUTSIDE OF THE PATIENT DURING THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICES REPORTED: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM (PART 03.010.487, LOT 8703634, QUANTITY 1). THIS REPORT IS FOR A CANNULATED CONNECTING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7953490 ↗