PTN Peritrochanteric Nail 28338Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304488076), received between Nov 11, 2021 and Nov 11, 2021 — classified as 1 injury.

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

3 other recalls cover devices cleared under the same FDA submission (K050118); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REPAIR MULTIPLE HIP FRACTURES. TWO YEARS POST IMPLANTATION, THE PATIENT'S DAUGHTER HAS REPORTED THAT THE FIXATION NAIL HAS BROKEN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12797121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050118. One submission often covers many models, so check the product and lot details in each record.

• Z-1819-2016 · Apr 1, 2016 · Terminated
  Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
• Z-1478-2012 · Mar 30, 2012 · Terminated
  REF 28234 Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx Sterile Biomet Trauma Persippany, NJ Rod, Fixation, Intramedullary and Accessories Product Usage: An
• Z-0012-06 · Jun 24, 2005 · Terminated
  EBI Trochanteric 11mm Long Nail.