EXPert Nail 04.001.428SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982081056), received between Oct 23, 2018 and Jun 5, 2019 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K033071); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, PATIENT UNDERWENT REMOVAL OF TITANIUM CANNULATED HUMERAL NAIL EX, TITANIUM LOCKING SCREW 30 MM AND TITANIUM LOCKING SCREW 38 MM. IMPLANTS WERE REMOVED DUE TO HUMERAL SHAFT NON-UNION. THE PATIENT ORIGINALLY HAD THE HUMERAL NAIL CONSTRUCT IMPLANTED TO TREAT HIS HUMERUS FRACTURE ON AN UNKNOWN DATE. PATIENT WAS REVISED TO A 9 HOLE 4.5 MM LCP BROAD PLATE AND EIGHT (8) 4.5 MM CORTEX SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8671461 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH ONE (1) TITANIUM END CAP T25 STARDRIVE, ONE (1) TITANIUM DISTAL LOCKING SCREW, ONE (1) TITANIUM CANNULATED HUMERAL NAIL-EX, STERILE, ONE (1) 38MM TITANIUM LOCKING SCREW AND ONE (1) TITANIUM SPIRAL BLADE ON AN OPEN REDUCTION INTERNAL FIXATION (ORIF) DUE TO PROXIMAL HUMERAL FRACTURE. AFTER THE INSERTION OF THE TITANIUM CANNULATED HUMERAL NAIL-EX THE BONE FAILED AROUND THE IMPLANT. THE SURGEON REMOVED THE TITANIUM END CAP T25 STARDRIVE, TITANIUM LOCKING SCREW AND THE TITANIUM SPIRAL BLADE AND RE-REDUCED THE HUMERAL HEAD ON TOP OF THE NAIL. THE ONLY IMPLANTS THAT REMAINED IN THE PATIENT WERE THE TITANIUM CANNULATED HUMERAL NAIL-EX AND THE TITANIUM DISTAL LOCKING SCREW. THE SURGEON INDICATED THAT THERE WAS CONCERN WITH THE PATIENTS BONE QUALITY AND POSSIBLY BONE CANCER. THERE WAS A NOTED ABNORMALITY ON THE X-RAY AND A CULTURE WAS TAKEN FROM THE POSSIBLE MALIGNANT TUMOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY. THIS REPORT IS FOR (1) 9MM TI CANNULATED HUMERAL NAIL-EX/240MM-STERILE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS 3 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7997431 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033071. One submission often covers many models, so check the product and lot details in each record.

• Z-0407-2014 · Jul 30, 2013 · Terminated
  Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.