Affixus® Natural Nail® 47-2486-044-40Recalls & 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 intramedullary nail is used to fix bone fractures. The 55 reports mostly describe screws and other parts of the implant loosening and shifting out of position after surgery, sometimes requiring a second operation to remove them, along with pain and slow healing. Reports include 50 injuries and no deaths. 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
- 57
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00889024505469), received between Jun 24, 2020 and Sep 22, 2026 — classified as 51 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Migration” (42 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
- Migration42
- Migration or Expulsion of Device21
- Patient Device Interaction Problem9
- Adverse Event Without Identified Device or Use Problem2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Appropriate Device Problem Term/Code Not Available1
- Device-Device Incompatibility1
- Human-Device Interface Problem1
Patient problems
- Failure of Implant29
- Insufficient Information21
- Pain15
- No Clinical Signs, Symptoms or Conditions10
- Needle Stick/Puncture2
- Aseptic loosening1
- Bone Fracture(s)1
- Impaired Healing1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Migration
It was reported that following implantation of an intramedullary nail, a proximal screw backed out approximately one month postoperatively. The event was identified during postoperative follow-up.The patient had no revision planned at the time of the report.Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855691 ↗InjuryApr 29, 2026Migration
IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT HAD UNDERWENT IM NAILING OF THE RIGHT PROXIMAL HUMERUS. SUBSEQUENT X-RAYS REVEALED EVIDENCE OF PROXIMAL SCREW LOOSENING AND PROTRUSION. THE PATIENT IS SCHEDULED FOR SCREW REMOVAL ON AN UNKNOWN DATE DUE TO PAIN FROM THE PROTRUDED SCREW. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Aseptic loosening; Loss of Range of Motion; Pain
MAUDE report 25030396 ↗InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23497591 ↗InjuryMay 13, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY WITH ANN NAIL. SUBSEQUENTLY, AFTER 4 WEEKS FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT 3 PROXIMAL SCREWS HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THESE SCREWS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 22011164 ↗InjuryDec 12, 2024Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 20916899 ↗InjuryMay 8, 2024Migration; Migration
InjuryMay 7, 2024Migration; Migration
NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19259014 ↗MalfunctionMar 21, 2024Migration; Migration
InjuryDec 21, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 18378493 ↗MalfunctionNov 21, 2023Migration; Migration
IT WAS REPORTED THAT PATIENT PRESENTED APPROXIMATELY 4 WEEKS POST INITIAL SURGERY AND IT WAS FOUND THAT TWO PROXIMAL SCREWS HAVE BACKED OUT OF THE ANN NAIL SYSTEM. AT THIS TIME, NO REVISION SURGERY IS PLANNED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 18184686 ↗InjuryJun 30, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 17236124 ↗InjuryJun 13, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 17115413 ↗InjuryJun 7, 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 SCREW. 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 17076864 ↗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 17036939 ↗InjuryMay 8, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT TWO (2) WEEKS AFTER INITIAL SURGERY, THE SURGEON FOUND ONE OF THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. REVISION SURGERY IS NOT PLANNED, AND THE PATIENT'S CONDITION WILL CONTINUE TO BE MONITORED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16884207 ↗InjuryMar 29, 2023Migration; Migration
IT WAS REPORTED THAT NINE DAYS AFTER INITIAL RIGHT HUMERAL NAIL IMPLANTATION THREE OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THEIR PROPER POSITION. NO INTERVENTION IS PLANNED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16635060 ↗InjuryJan 10, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 16129082 ↗InjuryJan 9, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE HIP DUE TO MIGRATION, APPROXIMATELY ONE (1) MONTH POST-OP. 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 16120000 ↗InjuryDec 14, 2022Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER SURGERY AND APPROXIMATELY AFTER 2 MONTHS A REVISION SURGERY WAS PERFORMED DUE TO A BACKED OUT SCREW.
Patient problems: Failure of Implant
MAUDE report 15976372 ↗InjuryDec 14, 2022Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER SURGERY AND APPROXIMATELY AFTER 2 MONTHS A REVISION SURGERY WAS PERFORMED DUE TO A BACKED OUT SCREW.
Patient problems: Failure of Implant
MAUDE report 15976332 ↗InjuryDec 14, 2022Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER SURGERY AND APPROXIMATELY AFTER 2 MONTHS A REVISION SURGERY WAS PERFORMED DUE TO A BACKED OUT SCREW.
Patient problems: Failure of Implant
MAUDE report 15975599 ↗InjuryAug 4, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ANN NAIL. AFTER 2 MONTHS FROM THE INITIAL SURGERY, THE SURGEON FOUND 2 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 15161933 ↗InjuryAug 4, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ANN NAIL. AFTER 2 MONTHS FROM THE INITIAL SURGERY, THE SURGEON FOUND 2 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 15161929 ↗InjuryJun 30, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP APPROXIMATELY SIX (6) MONTHS POST IMPLANTATION DUE TO MIGRATION. 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 14869447 ↗InjuryJun 6, 2022Migration; Migration
IT WAS REPORTED THAT THE SURGEON FOUND THAT 2 OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION APPROXIMATELY 1 MONTH AFTER THE IMPLANTATION. THE SURGEON IS KEEPING AN EYE ON THE PATIENT'S CONDITION AND NO REVISION IS PLANNED SO FAR. HARM NOT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 14601598 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
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- 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
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- TRIGEN 71674067Smith & Nephew, Inc. · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES201 reports
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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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