EXPert Nail 04.013.047Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982087485), received between Jan 9, 2018 and Oct 24, 2018 — classified as 3 injuries.

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.

• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT HARDWARE REMOVAL DUE TO INFECTION. THE DEVICES REMOVED WERE ONE (1) HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) TITANIUM SPIRAL BLADE, ONE (1) 6.0MM TITANIUM LOCKING SCREW, ONE (1) TITANIUM END CAP, ONE (1) TITANIUM LOCKING SCREW 50MM, AND TWO (2) TITANIUM LOCKING SCREWS 30MM. THE ORIGINAL IMPLANT FOR THE DEVICES IS (B)(6) 2018. THE PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: VIVIGEN FORMABLE BIOLOGIC TISSUE MATRIX (PRODUCT# BL-1600.002, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR (1) TI SPIRAL BLADE 75MM FOR TI RETROGRADE FEMORAL NAILS-EX. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 2 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8002124 ↗
• InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) 12MM HINDFOOT ARTHRODESIS CANNULATED NAIL, ONE (1) SPIRAL BLADE, ONE (1) END CAP, TWO (2) UNKNOWN 5MM LOCKING SCREWS, AND ONE (1) UNKNOWN 6MM LOCKING SCREW ON (B)(6) 2017. ON UNKNOWN DATE, PATIENT DEVELOPED AVASCULAR NECROSIS (AVN) AND NON-UNION. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. PATIENT WAS REVISED TO ONE (1) 4MM CANNULATED SCREW AND ONE (1) 6.5MM CANNULATED SCREW. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 75MM SPIRAL BLADE FOR RETROGRADE FEMORAL NAILS. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7698346 ↗
• InjuryJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HINDFOOT NAIL WAS IMPLANTED ON (B)(6) 2017 IN A DIABETIC PATIENT. EVENTUALLY SKIN NECROSED OVER SPIRAL BLADE SITE AND HARDWARE WAS EXPOSED. SO A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE THE BLADE AND THE WOUND WAS TREATED WITH A VACUUM-ASSISTED CLOSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR A HELICAL BLADE. THIS IS 1 OF 1 FOR (B)(4).

  Patient problems: Necrosis

  MAUDE report 7176615 ↗

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.