NA 207.610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982148049), received between Jul 7, 2020 and Jul 7, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE EXPERT TIBIAL NAIL, FIVE (5) 5.0MM LOCKING SCREWS AND TWO (2) 4.0MM CANNULATED SCREWS . THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS DUE TO NON-UNION AND THE PATIENT ANATOMY FELL INTO VALGUS FROM IMPLANT FAILURE. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW TIBIAL NAIL AND FIBULA LOCKING PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW SHORT THREAD/10MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

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

  MAUDE report 10240358 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE EXPERT TIBIAL NAIL, FIVE (5) 5.0MM LOCKING SCREWS AND TWO (2) 4.0MM CANNULATED SCREWS. THE REASON FOR THE REMOVAL OF THE IMPLANTS WAS DUE TO NON-UNION AND THE PATIENT ANATOMY FELL INTO VALGUS FROM IMPLANT FAILURE. DURING THE REVISION PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A NEW TIBIAL NAIL AND FIBULA LOCKING PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 4.0MM CANNULATED SCREW SHORT THREAD/10MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

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

  MAUDE report 10240141 ↗