EXPert Nail 04.034.446SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982095237), received between Aug 20, 2020 and Jan 12, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K040762); 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 16, 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 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A REMOVAL SURGERY OF TIBIAL NAIL WAS PERFORMED DUE TO INFECTION AND PLACEMENT OF ANTIBIOTIC BEADS. ORIGINAL IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2020. SURGICAL PROCEDURE OUTCOME AND PATIENT STATUS IS GOOD. CONCOMITANT DEVICES REPORTED: SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 5); END CAPS: TIBIAL NAIL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1)10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11154150 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT HARDWARE REMOVAL DUE TO NONUNION. THE DATE OF ORIGINAL IMPLANTATION WAS ON (B)(6) 2020. PATIENT WAS REVISED TO A NEW TIBIAL NAIL EX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS OKAY. THIS REPORT IS FOR A 10MM TITANIUM (TI) CANNULATED TIBIAL NAIL. THIS IS REPORT 1 OF 6 FOR (B)(4).

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

  MAUDE report 10489208 ↗
• MalfunctionAug 20, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A CASE, THE CONSULTANT NOTICED THAT THE TIBIAL NAIL'S COLOR WAS BLUE. NAIL IS USUALLY GREEN IN COLOR. THE CONSULTANT HAD A BACKUP DEVICE THAT HAD A CORRECT COLOR. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431382 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040762. One submission often covers many models, so check the product and lot details in each record.

• Z-2051-2015 · Jun 3, 2015 · Terminated
  TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.