EXPert Nail 04.003.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982081315), received between Dec 12, 2016 and Jun 1, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 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

  CONCOMITANT DEVICES REPORTED: NAILS: RAFN (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), NAIL INSERTION HANDLES (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), INSERTION INSTRUMENTS: CONNECTING/COUPLING SCREW: TRAUMA (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), EXPERT END CAP Ø12 CANN EXTENS. 10 F/LFN (PART NUMBER 04.003.002, LOT 4L91497, QUANTITY 1), EXPERT END CAP Ø12 CANN EXTENS. 15 F/LFN (PART NUMBER 04.003.003, LOT 22P9591, QUANTITY 1).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10105788 ↗
• InjuryApr 23, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ONE (1) RECON-NAIL AND TWO (2) RECON-SCREWS DURING A HIP SURGERY ON (B)(6) 2018. IT WAS NOTICED WITH THE HELP OF POST-OPERATIVE X-RAYS, THAT THE RECON SCREWS SEEMED TOO LONG, SO THE SURGEON BROUGHT THE PATIENT BACK TO THE SURGERY ON (B)(6) 2018 TO BACK THE SCREWS OUT A COUPLE OF TURNS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT STATUS WAS REPORTED TO BE FINE AT THE END OF THE PROCEDURE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 7452551 ↗
• InjuryDec 12, 2016Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING STAGE TWO REMOVAL OF EXTERNAL FIXATOR AND IMPLANTATION OF RETROGRADE FEMORAL NAIL PROCEDURE ON (B)(6) 2016, SURGEON SELECTED 5 MM END CAP AND IT WOULD NOT ENGAGE / DID NOT THREAD INTO THE NAIL. THEN SURGEON SELECTED 0 MM END CAP HOWEVER SECOND 5 MM END CAP WAS TESTED ON THE BACK TABLE WITH THE TRIAL RETROGRADE NAIL (EX RAFN NAIL) AND IT WAS ENGAGED AS PLANNED AND THEREFORE, 0 MM END CAP WAS REMOVED AND SECOND 5 MM END CAP WAS INSERTED WITHOUT ANY ISSUE. THERE WAS 5 MINUTES DELAY IN PROCEDURE AND THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT OUTCOME WAS REPORTED TO BE AS PLANNED. THE FIRST MALFUNCTIONED 5 MM END CAP WAS TESTED ON THE BACK TABLE WITH TRIAL EX RAFN NAIL AND IT WOULD NOT ENGAGE THE 5 MM END CAP WAS MANUALLY REMOVED WITH NEEDLE HOLDER. INTRA OPERATIVE UNPLANNED X-RAYS TAKEN TO RESOLVE END CAP PROBLEM AND WERE NOT AVAILABLE FOR REVIEW. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICES REPORTED: RETROGRADE FEMORAL NAIL (PART # 04.013.352S, LOT # 7316088, QUANTITY # 1), TRIAL EX RAFN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY #1). THIS REPORT IS 1 OF 1 FOR (B)(4)

  Patient problems: No Code Available

  MAUDE report 6167349 ↗

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.