Affixus® Natural Nail® 47-2486-040-40Recalls & reported problems
Zimmer GmbH · Class 2 · Implant
All models of Affixus Natural Nail (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer Affixus Natural Nail is an intramedullary nail used to fix broken bones. The reports mostly describe the nail and its screws shifting or backing out after surgery, sometimes with pain and the need to remove a screw. There are 67 reports, with no deaths and 47 injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00889024505445), received between Dec 24, 2019 and Sep 14, 2026 — classified as 48 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Migration” (54 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.
Reports received per month
Most reported problems
Device problems
- Migration54
- Migration or Expulsion of Device24
- Patient Device Interaction Problem8
- Loosening of Implant Not Related to Bone-Ingrowth3
- Adverse Event Without Identified Device or Use Problem1
- Expulsion1
- Material Integrity Problem1
- Separation Problem1
Patient problems
- Failure of Implant37
- Insufficient Information19
- Pain16
- No Clinical Signs, Symptoms or Conditions14
- No Code Available6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Bone Fracture(s)1
- Joint Dislocation1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Migration
It was reported that the patient underwent an initial procedure. Approximately two weeks post-implantation, a revision surgery was done due a screw that was found to have backed out from its proper position, causing pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50755761 ↗MalfunctionMay 20, 2026Migration
IT WAS REPORTED THAT TWO PROXIMAL SCREWS OF AN INTRAMEDULLARY NAIL BACKED OUT APPROXIMATELY TWO MONTHS POSTOPERATIVELY. THE PATIENT WAS MONITORED AND NO REVISION WAS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237094 ↗MalfunctionJan 26, 2026Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PROCEDURE WITH AN INTRAMEDULLARY NAIL, AFTER WHICH ONE PROXIMAL SCREW BACKED OUT APPROXIMATELY 2 WEEKS POSTOPERATIVELY. THE PATIENT REMAINED UNDER CLINICAL OBSERVATION AND NO REVISION HAS BEEN PLANNED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176237 ↗MalfunctionOct 31, 2025Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23437332 ↗InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT WAS ORIGINALLY IMPLANTED WITH THE AFFIXUS HUMERAL NAIL, APPROXIMATELY 10 MONTHS POST IMPLANTATION PATIENT UNDERWENT REMOVAL OF A SCREW DUE TO UNKNOWN SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21921218 ↗MalfunctionMar 12, 2025Migration; Separation Problem; Migration; Separation Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 21584876 ↗InjuryDec 26, 2024Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 21021126 ↗InjuryDec 26, 2024Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 21021097 ↗MalfunctionNov 18, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20707706 ↗MalfunctionNov 18, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20707575 ↗MalfunctionSep 17, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 20238574 ↗MalfunctionAug 21, 2024Migration; Migration
IT WAS REPORTED THAT AFTER 9 MONTHS FROM THE INITIAL IMPLANTATION ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT'S HEALTH IS FINE, THE SCREW HAS NOT BEEN REMOVED AND NO REVISION SURGERY HAS BEEN PERFORMED. THERE IS NO REPORTED HARM OR INJURY TO THE PATIENT, HOWEVER THIS MALFUNCTION HAS CAUSED A SERIOUS INJURY IN THE PAST. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE ALL AVAILABLE ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Patient problems: Failure of Implant
MAUDE report 20015235 ↗InjuryAug 14, 2024Migration; Migration
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19986340 ↗InjuryAug 14, 2024Migration; Migration
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19986264 ↗MalfunctionAug 6, 2024Migration; Migration
IT WAS REPORTED THAT 4 WEEKS AFTER THE INITIAL SURGERY, SURGEON FOUND #2 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION AS WELL, AS NO REVISION WILL BE PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 19919642 ↗InjuryJan 30, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 18606730 ↗InjuryDec 11, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION, APPROXIMATELY ONE (1) MONTH AFTER IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Pain
MAUDE report 18307486 ↗InjuryJul 20, 2023Migration; Migration
IT WAS REPORTED THAT PROXIMAL SCREW BACKED OUT FROM THE PROPER POSITION AFTER FOUR (4) WEEKS FROM THE INITIAL SURGERY. NO REVISION PLANNED SO FAR. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17358976 ↗InjuryJun 30, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 17236027 ↗InjuryJun 22, 2023Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE AND AFTER APPROXIMATELY (6) WEEKS FROM THE INITIAL, THE SURGEON FOUND THAT THE PROXIMAL SCREW BACKED OUT FROM THE PROPER POSITION. PATIENT IS UNDER HEALTH PROFESSIONAL'S OBSERVATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17186587 ↗InjuryJun 13, 2023Migration; Migration
IT WAS REPORTED THAT AFTER TWO WEEKS AFTER THE INITIAL SURGERY, TWO PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL MONITOR THE PATIENT'S CONDITION. NO REVISION HAS BEEN PLANNED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17115992 ↗InjuryJun 13, 2023Migration; Migration
IT WAS REPORTED THAT DURING THE INITIAL SURGERY, THE PATIENT WAS IMPLANTED WITH ANN NAIL. 6 WEEKS AFTER THE SURGERY ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION AND THE PATIENT EXPERIENCED PAIN. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE MIGRATED SCREW. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 17115407 ↗InjuryJun 1, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17036940 ↗InjuryApr 26, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16813095 ↗InjuryApr 25, 2023Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL SURGERY AND APPROXIMATELY AFTER 6 WEEKS THE SURGEON FOUND THAT THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED TO REMOVE THESE SCREWS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Pain
MAUDE report 16805461 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- NA 03.037.026Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES225 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-075Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls2 reports
- PRECICE® Intramedullary Limb Lengthening System LSC5-045Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- PRECICE® Intramedullary Limb Lengthening System LSC5-050Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls1 report
- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
- PRECICE Intramedullary Limb Lengthening System LSB5-040Nuvasive Specialized Orthopedics, Inc. · Rod, Fixation, Intramedullary And Accessories4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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