EXPert Nail 04.003.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982081353), received between Jun 1, 2020 and Jun 1, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K033618, K040336, K172157); 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.

• InjuryJun 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE PATIENT WAS UNDERWENT FOR FEMORAL DIAPHYSIS FRACTURE SURGERY ON (B)(6) 2020. DURING THE SURGERY, THE CLOSING PLUG #10 WAS UNABLE TO ENTER COMPLETELY. IT WAS ATTEMPTED WITH # 15 THAT IF IT CLOSED BUT IT WAS TOO LONG THEN IT WAS NOT INDICATED. ALSO, USED #5 PLUG BUT FAILED TO SHUT PROPERLY AND ALMOST IMPOSSIBLE TO REMOVE IT. THE SURGERY WAS DELAYED ONE (1) HOUR. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10105794 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618, K040336, K172157. 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.