NA 459.56Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982231635), received between Feb 15, 2018 and Feb 15, 2018 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K914371, K923580, K954856, K962047, K970097, K970733); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT SUSTAINED A BROKEN LEFT FEMUR IN A MOTOR VEHICLE ACCIDENT IN (B)(6) 2010. PATIENT WAS IMPLANTED WITH THE TROCHANTERIC NAIL SYSTEM ON UNKNOWN DATE. PATIENT REPORTS PAIN IN THE LEFT LEG. PATIENT HAS HAD FOLLOW UP VISITS TO THE DOCTOR BUT DOES NOT KNOW IF EXPLANTATION OF THE DEVICES IS PLANNED. X-RAYS TAKEN ON UNKNOWN DATE INDICATE THE BONE IS GROWING OVER THE NAIL. THIS REPORT IS FOR ONE (1) 4.9MM LOCKING BOLT. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 7275604 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K914371, K923580, K954856, K962047, K970097, K970733. One submission often covers many models, so check the product and lot details in each record.

• Z-2243-2013 · Apr 18, 2013 · Terminated
  Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.