EXPert Nail 04.003.461SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982082282), received between Jul 29, 2019 and Jul 29, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2019Use of Device Problem; Use of Device Problem

  UPDATED EVENT DESCRIPTION ON (B)(6) 2019 PATIENT HAD FRACTURED R FEMUR WITH INTERMEDULLARY NAILING BUT CONTINUED TO HAVE DIFFICULTY WITH R LE AS WELL AS INCREASING KNEE PAIN. AND WENT IN FOR A SECOND OPINION AND FOUND THAT THE SURGERY HAD L INTERMEDULLARY NAIL INSTEAD OF A R INTERMEDULLARY NAIL. AS PER DOCTOR REPORTS THAT THE INTERMEDULLARY NAIL WAS POSITION INCORRECTLY. THIS MADE THE NATURAL CURVE OF THE FEMUR INCORRECT. HE ALSO REPORTS R KNEE PAIN THAT WAS NOT PRESENT PRIOR TO FEMUR FRACTURE IN MARCH. HE REPORTS THAT HE HAS HAD A MRI OF KNEE THAT WAS NEGATIVE. ' ON (B)(6) 2019 PATIENT HAD REVISED DUE TO COMMINUTED FRACTURE OF SHAFT OF RIGHT FEMUR, SUBSEQUENT ENCOUNTER CLOSED FRACTURE WITH MALUNION. THIS COMPLAINT INVOLVES FIVE (5) NUMBER OF DEVICES ADDITIONAL UPDATES MADE ON THIS COMPLAINT: ADDED SCREWS AS IP SINCE IT WAS MENTION OF SUBSEQUENT ENCOUNTER CLOSED FRACTURE WITH MALUNION. PRODUCTS FOUND IN IMPLANT RECORD (B)(4). ALSO ADDED LOT NUMBER FOR THE REPORTED NAIL. ADDED MEDICAL HISTORY AND RELEVANT TEST/LAB DATA. CORRECTED PATIENT'S GENDER AND INITIALS.

  Patient problems: Malunion of Bone; No Code Available

  MAUDE report 8837021 ↗

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.