Affixus® Natural Nail® 47-2486-048-40Recalls & 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 a metal rod used to fix broken bones, such as the upper arm, inside the bone. The 34 reports mostly describe the nail's screws loosening and backing out of place after surgery, sometimes requiring a second operation to remove them, along with pain and bone tissue dying. No deaths were reported, but 32 injuries were. There are no recalls naming 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
- 34
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00889024505483), received between Jan 20, 2020 and Feb 2, 2026 — classified as 32 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Migration” (22 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
- Migration22
- Migration or Expulsion of Device10
- Patient Device Interaction Problem5
- Adverse Event Without Identified Device or Use Problem2
- Expulsion2
- Mechanical Problem1
- Separation Problem1
- Unintended Movement1
Patient problems
- Failure of Implant20
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions7
- Pain7
- Necrosis2
- No Code Available2
- Aseptic loosening1
- No Information1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Migration; Separation Problem
IT WAS REPORTED FROM A CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL RIGHT PROXIMAL HUMERAL NAILING, AND SCREW LOOSENING WAS INCIDENTALLY IDENTIFIED ON RADIOGRAPHS APPROXIMATELY 6 WEEKS POST-IMPLANTATION. SUBSEQUENTLY, THE PATIENT EXPERIENCED A FALL AND SUSTAINED A FRACTURE OF THE LEFT HUMERUS; THE LEFT SIDE HAD NO IMPLANTS AND WAS MANAGED CONSERVATIVELY WITHOUT SURGICAL INTERVENTION. DURING THE NEXT FOLLOW-UP VISIT APPROXIMATELY 3 WEEKS LATER, RADIOGRAPHS SHOWED LOOSENING OF A SECOND SCREW, WHILE THE FIRST SCREW REMAINED UNCHANGED. NO ACTION WAS TAKEN AS THE PATIENT WAS NOT REPORTING PAIN OR DISCOMFORT. THE PATIENT DID NOT REQUIRE SURGICAL INTERVENTION AND REMAINED ASYMPTOMATIC. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24229171 ↗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 23497430 ↗MalfunctionJul 24, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY WITH ANN NAIL. SUBSEQUENTLY, 9 DAYS POST IMPLANTATION, SURGEON FOUND THREE OF THE PROXIMAL SCREWS WERE 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. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22587001 ↗InjuryJun 9, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO LOOSENING OF PROXIMAL HEAD SCREW. THE SUBJECT IS REPORTED AS IMPROVED/RECUPERATED 5 MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Aseptic loosening; Failure of Implant; Pain
MAUDE report 22167672 ↗InjuryMay 13, 2025Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 22011180 ↗InjuryApr 29, 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 3 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 21925015 ↗InjuryMay 20, 2024Migration; Migration
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL. APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT COMPLAINED OF PAIN AND THE SURGEON FOUND #3 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19351143 ↗InjuryJan 29, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 18599786 ↗InjuryJul 25, 2023Migration; Migration
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 17036941 ↗InjuryApr 3, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16663034 ↗InjuryMar 30, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16641954 ↗InjuryMar 29, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16635057 ↗InjuryFeb 21, 2023Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY THREE (3) MONTHS AFTER IMPLANTATION, DURING A ROUTINE POST-OPERATIVE CHECK-UP, IT WAS FOUND OUT THAT THE PROXIMAL SCREW HAD BACKED OUT FROM THE PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 16406645 ↗InjuryDec 21, 2022Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY THREE (3) MONTHS AFTER IMPLANTATION, DURING A ROUTINE POST-OPERATIVE CHECKUP, IT WAS FOUND OUT THAT A PROXIMAL SCREW HAD BACKED OUT FROM THE PROPER POSITION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 16021040 ↗InjuryNov 18, 2022Migration; Migration
IT WAS REPORTED THAT 2-MONTH POST-IMPLANTATION, A SCREW BACKED OUT FROM ITS CORRECT POSITION. NO REVISION SURGERY IS CURRENTLY SCHEDULED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 15824037 ↗InjuryOct 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO SCREW MIGRATION 3-MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 15602995 ↗InjuryOct 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO SCREW MIGRATION 3-MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 15602994 ↗InjurySep 5, 2022Expulsion; Expulsion
IT WAS REPORTED THAT 6 WEEKS AFTER IMPLANTATION, PATIENT EXPERIENCED HUMERAL HEAD NECROSIS. PROXIMAL SCREW NEXT TO THE SCREW HOLE HAD MIGRATED. REVISION SURGERY HAS BEEN PERFORMED ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Necrosis
MAUDE report 15354788 ↗InjuryAug 3, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT APPROXIMATELY FOUR WEEKS AFTER INITIAL SURGERY, THE PATIENT UNDERWENT REVISION DUE TO SCREW MIGRATION.
Patient problems: Failure of Implant
MAUDE report 15155939 ↗InjuryJul 14, 2022Migration; Migration
IT WAS REPORTED THAT THE SURGEON FOUND THAT THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION 1 MONTH AFTER THE INITIAL SURGERY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION. REVISION SURGERY IS NOT CURRENTLY PLANNED. NO FURTHER PATIENT OUTCOME WAS PROVIDED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15014061 ↗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 14869490 ↗InjuryMay 11, 2022Migration or Expulsion of Device; Expulsion; Migration or Expulsion of Device; Expulsion
IT WAS REPORTED THAT 6 WEEKS AFTER IMPLANTATION, PATIENT EXPERIENCED HUMERAL HEAD NECROSIS. PROXIMAL SCREW NEXT TO THE SCREW HOLE HAD MIGRATED. REVISION SURGERY HAS BEEN PLANNED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.
Patient problems: Failure of Implant; Necrosis
MAUDE report 14352021 ↗InjuryApr 19, 2022Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH NAIL. AFTER 2 MONTH FROM THE INITIAL, SURGEON FOUND #1 SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR.
Patient problems: Insufficient Information
MAUDE report 14141249 ↗InjuryFeb 17, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 4 WEEKS FROM THE INITIAL, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13549239 ↗
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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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