NA 357.418Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982196415), received between Aug 10, 2018 and Aug 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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 10, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) INSERTION PROCEDURE. DURING THE SURGERY, THE HELICAL BLADE WOULD NOT GO THROUGH THE NAIL. THE SURGEON ATTEMPTED TO INSERT THE HELICAL BLADE MULTIPLE TIMES. HOWEVER, THE BLADE WOULD NOT GO THROUGH THE NAIL. THE SURGEON FINALLY DECIDED TO CHANGE THE INSERTION HANDLE AND CONNECTING SCREW AND WAS ABLE TO SUCCESSFULLY INSERT THE HELICAL BLADE. A SECOND HELICAL BLADE WAS USED AS THE FIRST HELICAL BLADE WAS SCRATCHED FROM TRYING TO INSERT IT. THERE WAS A TWO-HOUR SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH SATISFACTORY PATIENT OUTCOME. CONCOMITANT DEVICE REPORTED: TFN NAIL (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) PERCUTANEOUS INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7774362 ↗