EXPert Nail 04.003.460SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982082275), received between Dec 26, 2017 and Mar 7, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K040336); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2018Break; Break

  (B)(4) IT WAS REPORTED A PATIENT ORIGINALLY FELL ON OR AROUND (B)(6) 2017 AND WAS TREATED SURGICALLY FOR AN INITIAL RIGHT INTERTROCHANTERIC FEMUR FRACTURE WITH AN 11 MM LATERAL FEMORAL NAIL. THE EXACT IMPLANT DATE IS UNKNOWN. SUBSEQUENTLY, THE PATIENT FELL A SECOND TIME ON AN UNKNOWN DATE IN (B)(6) 2017. IT WAS DETERMINED THE FEMORAL NAIL BROKE AND THE PATIENT PRESENTED WITH A NON-UNION. IT IS POSSIBLE THE SECONDARY FALL LED TO THE DEVICE FAILURE. IT IS UNKNOWN IF A REVISION SURGERY OCCURRED AND DEVICES WERE EXPLANTED. PATIENT STATUS IS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7322620 ↗
• InjuryDec 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION OF A 11 MM LATERAL ENTRY FEMORAL RECON NAIL AND AT LEAST TWO (2) RECON SCREWS (5.0 MM LOCKING SCREWS) ON (B)(6) 2017 DUE TO NONUNION. ALL DEVICES WERE REMOVED INTACT, AND THE PATIENT WAS THEN REVISED TO ANOTHER RECON NAIL. THERE WERE NO COMPLICATIONS DURING THE REVISION OF THE IMPLANTS AND NO ADDITIONAL INTERVENTIONS WERE REQUIRED TO COMPLETE THE SURGERY SUCCESSFULLY. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THIS COMPLAINT INVOLVES AT LEAST THREE (3) DEVICES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR THE NAIL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7146027 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040336. One submission often covers many models, so check the product and lot details in each record.

• Z-1915-2015 · May 27, 2015 · Terminated
  DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Sub
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.