EXPert Nail 04.013.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982087447), received between Aug 29, 2017 and Jan 27, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033618); 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 (B)(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) TI SPIRAL BLADE 65MM FOR TI RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11240275 ↗
• InjuryApr 12, 2018Unintended Movement; Unintended Movement

  DEVICE REPORT REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AFTER THE PATIENT WAS OPERATED A MONTH AGO FOR AN ANKLE ARTHRODESIS, THE SPIRAL BLADE MIGRATED TO ANOTHER PLACE FROM THE NORMAL LOCATION. THE DEVICE MIGRATED WAS IDENTIFIED FROM POST OP X-RAYS. THE PATIENT REPORTS NO FALLS AFTER ORIGINAL PROCEDURE. ORIGINAL PROCEDURE WAS PERFORMED IN (B)(6) 2018 AND PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT WAS REPORTED AS STABLE POST-OPERATIVELY. THE EXPLANT OPERATION OF SPIRAL BLADE WAS (B)(6) 2018. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7426486 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS RETURNED TO THE OPERATING ROOM (OR) ON (B)(6) 2017 FOR A NON-UNION OF A HINDFOOT FUSION THAT RESULTED IN THE REMOVAL OF ONE (1) TITANIUM 10 MM HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) TITANIUM SPIRAL BLADE, ONE (1) 6.0 MM LOCKING SCREW, THREE (3) 5.0 MM LOCKING SCREWS AND ONE (1) TITANIUM END CAP. THE SURGEON STATED THAT THIS WAS NOT IMPLANT RELATED AND DELAYED HEALING WAS CAUSED BY DIABETES. THE ORIGINAL NAIL WAS IMPLANTED ON (B)(6) 2015. THE NAIL WAS REMOVED, THE SITE WAS BONE GRAFTED WITH PATIENT ILIAC CREST GRAFT AND A NEW HINDFOOT NAIL IMPLANTED. THE PROCEDURE WAS SUCCESSFUL AND PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) SPIRAL BLADE FOR RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6827908 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.