EXPert Nail 04.031.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982093806), received between Jul 12, 2018 and Jul 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 12, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT IMPLANTATION OF AN ADOLESCENT LATERAL-ENTRY FEMORAL NAIL (ALFN). DURING THE PROCEDURE, THE SURGEON STRUGGLED TO THREAD THE TITANIUM (TI) END CAP T40 STARDRIVE 5MM EXT FOR ADOLESCENT LFN-EX INTO THE END OF THE NAIL, AS WELL AS TO GET THE END CAP TO FULLY SEAT TO ITS APPROPRIATE DEPTH. THE SURGEON DECIDED TO REMOVE THE END CAP AND DID NOT USE ANY REPLACEMENT IN THE NAIL. UPON INSPECTING THE THREADS OF THE END CAP AFTER IT WAS REMOVED, THE SCRUB TECHNICIAN NOTICED THE THREADS WERE A LITTLE DAMAGED. IT IS UNKNOWN IF THIS DAMAGE OCCURRED BEFORE THE SURGEON TRIED INSERTING THE END CAP INTO THE NAIL OR AS A RESULT OF THE SURGEON TRYING TO INSERT IT INTO THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH A REPORTED DELAY OF TEN TO FIFTEEN (10-15) MINUTES. PATIENT STATUS WAS STABLE. CONCOMITANT DEVICE: ALFN (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A TI END CAP T40 STRDRV 5MM EXT FOR ADOLESCENT LFN-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7682110 ↗