Phantom® Fibula Nail System P36-128-130R-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889795133670), received between Oct 15, 2025 and Oct 15, 2025 — classified as 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 13, 2025Class IIOpen, Classified

   Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.

   Z-0871-2026 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionOct 15, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE NAIL DID NOT CONNECT PROPERLY TO THE NAIL GUIDE. THE CASE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT NAIL; DELAY OF SURGERY WAS LESS THAN 30 MINUTES. NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304161 ↗
• MalfunctionOct 15, 2025Unintended Movement; Unintended Movement

  THE FIBULAR NAIL DID NOT SIT FLUSH OR TIGHTEN PROPERLY TO THE OUTRIGGER WHEN CORRECTLY POSITIONED. THIS RESULTED IN A DELAY OF APPROXIMATELY 30 MINUTES TO TROUBLESHOOT THE PROBLEM. THE NAIL WAS REMOVED FROM THE PATIENT AND UPSIZE TO THE NEXT SIZE NAIL TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO REPORT OF PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303569 ↗