Zimmer® Natural Nail® System 47-2485-100-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024298453), received between Jun 12, 2019 and Jul 1, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Difficult to Insert; Malposition of Device

  IT WAS REPORTED THAT A LAG SCREW AND INSERTER COULD NOT FULLY THREAD DURING A PROCEDURE. THERE WAS A SMALL GAP BETWEEN THE INSERTER AND LAG SCREW. THE LAG SCREW WAS ABLE TO BE IMPLANTED BUT FULL COMPRESSION WAS NOT ACHIEVED. THEREFORE THE LAG SCREW IS NOT SERVING ITS INTENDED PURPOSE AND IS CONSIDERED A FOREIGN BODY. THE ISSUE WAS IDENTIFIED INTRA-OPERATIVELY DURING SCREW PLACEMENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25677339 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY APPROXIMATELY ONE (1) YEAR AFTER IMPLANTATION DUE TO PAIN AND PSEUDOARTHROSIS. THE NAIL WAS REMOVED WITHOUT DIFFICULTY, AND A TOTAL HIP ARTHROPLASTY WAS PERFORMED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 19548440 ↗
• InjuryAug 18, 2023Migration; Migration

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Failure of Implant

  MAUDE report 17572441 ↗
• InjuryJul 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION SURGERY, WHILE ATTEMPTING TO REMOVE THE LAG SCREW, THE LAG SCREW SNAPPED, THEREFORE NOT ALLOWING REMOVAL OF NAIL AND SCREW. NAIL WAS LEFT IN SITU. PLATING WAS REQUIRED AND THERE WAS AN INCREASE IN SURGICAL TIME. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 17387894 ↗
• MalfunctionSep 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12428149 ↗
• InjuryFeb 18, 2021Fracture; Fracture

  INVESTIGATION HAS BEEN COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11343220 ↗
• MalfunctionAug 30, 2019Difficult to Insert; Difficult to Insert

  PLEASE REFER TO REPORT 0009613350-2019-00543.

  Patient problems: No Code Available

  MAUDE report 8949610 ↗
• InjuryJun 12, 2019Difficult to Remove; Difficult to Remove

  IN ADDITION TO REPORT 0009613350-2019-00381, 1 SCREW (LOCKING SCREW) COULD BE REMOVED. TWO FINS OF THE SECOND (CERVICAL) SCREW BROKE. THE SCREW COULD BE SCREWED OUT 1CM AND THEN THE SCREW WAS ATTEMPTED TO BE REMOVED WITH PLIERS, HOWEVER WITHOUT ANY SUCCESS. TOTAL DELAY REPORT, 1 HOUR.

  Patient problems: No Code Available

  MAUDE report 8690333 ↗