Zimmer® Natural Nail® System 47-2493-213-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024298958), received between Feb 22, 2019 and Mar 30, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2021Fracture; Fracture

  PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT A REVISION SURGERY DUE TO IMPLANT FRACTURE. THE MATERIAL COULD NOT BE REMOVED AS THE WINGS OF THE CEPHALIC SCREW HAVE FRACTURED. THE NAIL AND THE CEPHALIC SCREW REMAIN INSIDE THE PATIENT. A SURGICAL DELAY OF UNKNOWN TIME HAS ALSO OCCURRED.

  Patient problems: Failure of Implant; Foreign Body In Patient; Insufficient Information

  MAUDE report 11588583 ↗
• MalfunctionJul 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING SURGERY THE SURGEON FACED DIFFICULTIES WHILE IMPLANTING. IT WAS NOTED THAT CEPHALIC MILLER DID NOT GET THROUGH THE NAIL DESPITE THE FAVORABLE CONTROL BEFORE IMPLANTATION. THE NAIL WAS REMOVED AND REPLACED BY ANOTHER ONE. THE SURGERY WAS EXTENDED BY ABOUT 15 MINUTES.

  Patient problems: No Code Available

  MAUDE report 10239111 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON ADDITIONAL INFORMATION RECEIVED ON 28- NOV-2019 WE REALIZED THAT WE ARE NOT THE LEGAL MANUFACTURER OF THE DEVICE. THE LEGAL MANUFACTURER IS ZIMMER BIOMET WARSAW. IN THE MEANTIME THIS EVENT HAS BEEN CAPTURED UNDER WARSAW (B)(4) AND HAS BEEN LINKED TO WINTERTHUR (B)(4). AS THIS EVENT IS CAPTURED UNDER WARSAW (B)(4), THIS COMPLAINT WILL BE SET TO NOT A COMPLAINT. SO PLEASE VOID IT FROM YOUR DATABASE

  Patient problems: No Information

  MAUDE report 9382072 ↗
• InjuryFeb 22, 2019Fracture; Fracture

  IT WAS REPORTED THAT A IMPLANT FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 8361380 ↗