Small Bone Phantom Intramedullary Nail System P30-R1-5544Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889795039101), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 injury.

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

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.

• InjurySep 25, 2020Break

  IT WAS REPORTED THAT NINE MONTHS AFTER IMPLANTATION, A PHANTOM 4-HOLE INTRAMEDULLARY NAIL BROKE AT THE DISTAL CUNEIFORM HOLE. THE PATIENT HAD REPORTED PAIN AT THE AREA OF FUSION AND THE SURGEON CONFIRMED A NONUNION AT THE FIRST TARSOMETATARSAL JOINT. IT WAS REPORTED THAT PATIENT WAS COMPLAINT TO POST OPERATIVE INSTRUCTIONS PROVIDED BY THE SURGEON. A REVISION SURGERY WAS COMPLETED ON (B)(6) 2020 TO REMOVE THE BROKEN HARDWARE.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 10584760 ↗