EXPert Nail 04.003.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982081339), received between Jan 15, 2018 and Jun 1, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (2 reports).

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 3 most recent of 3 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 5 OF 6 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10105795 ↗
• MalfunctionJan 15, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT TWO DIFFERENT 10 MM END CAPS WOULD NOT THREAD INTO THE NAIL DURING A RIGHT LATERAL ENTRY FEMORAL NAIL PROCEDURE ON (B)(6) 2017. THE SURGEON HAD PLACED THE 9X340 NAIL AND WENT TO PLACE A 10 MM END CAP IN THE PROXIMAL PORTION OF THE NAIL. HE TRIED TWO DIFFERENT 10 MM END CAPS AND NEITHER WOULD THREAD INTO THE NAIL. HE THEN WENT AND PLACED A 15 MM END CAP AND HAD NO PROBLEM GETTING IT TO ENGAGE AND THREAD IN. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH GOOD PATIENT OUTCOME. CONCOMITANT DEVICE REPORT: 9X340 NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7191193 ↗
• MalfunctionJan 15, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT TWO DIFFERENT 10 MM END CAPS WOULD NOT THREAD INTO THE NAIL DURING A RIGHT LATERAL ENTRY FEMORAL NAIL PROCEDURE ON (B)(6) 2017. THE SURGEON HAD PLACED THE 9X340 NAIL AND WENT TO PLACE A 10 MM END CAP IN THE PROXIMAL PORTION OF THE NAIL. HE TRIED TWO DIFFERENT 10 MM END CAPS AND NEITHER WOULD THREAD INTO THE NAIL. HE THEN WENT AND PLACED A 15 MM END CAP AND HAD NO PROBLEM GETTING IT TO ENGAGE AND THREAD IN. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH GOOD PATIENT OUTCOME. CONCOMITANT DEVICE REPORT: 9X340 NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7191178 ↗

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.