EXPert Nail 04.008.016SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982087171), received between Apr 17, 2018 and Jan 27, 2021 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (K051678); 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.

• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON JANUARY 6, 2021, THE PATIENT UNDERWENT A REMOVAL OF TITANIUM HINDFOOT ARTHRODESIS CANNULATED NAIL DUE TO NONUNION. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS A PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 10MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/RT-STERILE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11240323 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT INITIAL SURGERY WHEREIN A RIGHT HIND FOOT ARTHRODESIS NAIL WAS IMPLANTED ALONG WITH REAMER/IRRIGATOR/ASPIRATOR (RIA). IT WAS ON A TIBIAL SHAFT FROM THE HIND FOOT WITH A 12MM RIA HEAD TO GET AN AUTO GRAFT WITH THE PATIENT THAT HAD A LARGE VOID IN THE DISTAL TIBIA. THUS, THE HINDFOOT NAIL WAS IMPLANTED. THE NAIL WAS IMPLEMENTED CORRECTLY WITH 26MM, 44MM, 64MM, AND 60MM TITANIUM LOCKING SCREWS AND AN END CAP. ON (B)(6) 2019, PATIENT UNDERWENT A HIND FOOT NAIL REMOVAL AND WAS IMPLANTED WITH A MEDICAL VALOR NAIL. THE REASON FOR NAIL REMOVAL WAS DUE TO FEELING TOO MUCH VALGUS DID THE BEND OF THE NAIL. THE SURGEON WANTED TO TAKE IT OUT AND PUT IN A STRAIGHT NAIL. THERE WAS NO FAILURE WITH THE IMPLANTS. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES: 26MM TITANIUM LOCKING SCREWS( PART 04.005.516, LOT UNKNOWN, QUANTITY 1), 44MM TITANIUM LOCKING SCREWS (PART 04.005.534, LOT UNKNOWN, QUANTITY 1), 64MM TITANIUM LOCKING SCREW (PART 04.005.654, LOT UNKNOWN, QUANTITY 1), 60MM TITANIUM LOCKING SCREW (PART 04.005.650, LOT UNKNOWN, QUANTITY 1), TITANIUM END CAP (PART 04.008.001, LOT U

  Patient problems: No Code Available

  MAUDE report 8286402 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL OF A HIND-FOOT NAIL TOOK PLACE ON (B)(6) 2018 DUE TO NONUNION OF SUBTALAR JOINT. THE NAIL WAS REMOVED, ILIAC BONE GRAFT WAS TAKEN TO GRAFT THE NONUNION AND 6.5/7.3 CANNULATED SCREWS WERE INSERTED FOR FIXATION. PROCEDURE COMPLETED SUCCESSFULLY WITH NO DELAY IN SURGERY. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7438747 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051678. One submission often covers many models, so check the product and lot details in each record.

• Z-1234-2024 · Jan 24, 2024 · Open, Classified
  13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability