Affixus® Natural Nail® 47-2496-160-11Recalls & 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 nail is an implanted rod used to fix broken bones. Reports mostly describe screws moving out of position weeks after surgery, with pain and follow-up surgery to remove screws. There are 24 reports mentioning its identifier, with no deaths and 20 injuries. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024505797), received between Sep 29, 2020 and May 13, 2025 — classified as 20 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Migration” (13 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
- Migration13
- Separation Problem5
- Patient Device Interaction Problem3
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Device-Device Incompatibility1
- Material Integrity Problem1
Patient problems
- Failure of Implant14
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions5
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain1
- No Code Available1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2025Separation Problem; Separation Problem
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 22011183 ↗MalfunctionSep 3, 2024Separation Problem; Separation Problem
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 20124060 ↗MalfunctionJul 5, 2024Separation Problem; Separation Problem
IT WAS REPORTED THAT SEVEN WEEKS PORT-IMPLANTATION, SURGEON FOUND #2 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEPS 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 19681729 ↗InjuryMay 8, 2024Separation Problem; Separation Problem
InjuryMay 7, 2024Separation Problem; Separation Problem
NO ADDITIONAL INFORMATION AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19259016 ↗InjuryJun 6, 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 17071330 ↗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 17036938 ↗InjuryMar 30, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16641956 ↗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 16633512 ↗InjuryFeb 21, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16406643 ↗InjurySep 29, 2022Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO SCREW MIGRATION, APPROXIMATELY 2 WEEKS POST OPERATION. 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 15508205 ↗InjurySep 13, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SURGERY AND APPROXIMATELY 2 MONTHS POST-OP, REVISION SURGERY WAS PERFORMED DUE TO A SCREW MIGRATION. ONLY THE MIGRATED SCREW WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 15409395 ↗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 15014006 ↗InjuryMar 24, 2022Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO MIGRATION.
Patient problems: Failure of Implant; Pain
MAUDE report 13889239 ↗InjuryMar 23, 2022Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT A OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 5 WEEKS FROM THE INITIAL, SURGEON FOUND ONE 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; No Clinical Signs, Symptoms or Conditions
MAUDE report 13868517 ↗InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 2 WEEKS FROM THE INITIAL, SURGEON FOUND THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. THEREFORE, REVISION SURGERY WAS PERFORMED. PAIN AT THE FRACTURE SITE. PAIN DUE TO SCREW PROTRUSION.
Patient problems: Implant Pain
MAUDE report 13692814 ↗MalfunctionNov 19, 2021Mechanical Problem; Migration or Expulsion of Device; Mechanical Problem; Migration or Expulsion of Device
INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 12842756 ↗InjurySep 3, 2021Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE WITH AN ANN NAIL SYSTEM. A WEEK POST THE IMPLANTATION SURGERY THE SURGEON NOTICED THAT THE THIRD BLUNT SCREW HAD BACKED OUT FROM ITS PROPER POSITION. HENCE, THE PATIENT UNDERWENT A REVISION SURGERY DURING WHICH THE THIRD BLUNT SCREW WAS EXPLANTED. THE TORQUE DRIVER WAS USED TO ENGAGE THE CORELOCK, FURTHERMORE NON-TORQUE DRIVER WAS USED TO TIGHTEN MORE AFTER USING THE TORQUE DRIVER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant
MAUDE report 12421520 ↗MalfunctionJul 29, 2021Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12249191 ↗InjuryJun 4, 2021Migration; Migration
PATIENT WAS IMPLANTED WITH ANN NAIL ON AN UNKNOWN SIDE, 10 DAYS POST IMPLANTATION IT WAS REPORTED THAT THE 2ND SCREW HAD MIGRATED FROM ITS POSITION. THE REVISION SURGERY IS NOT PLANNED YET.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11937859 ↗InjuryNov 23, 2020Migration; Migration
PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO SCREWS BACKED OUT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10884193 ↗InjuryOct 7, 2020Migration; Migration
THE FOLLOWING PRODUCT ITEM# 47249616011 AND LOT# 3007826 HAS BEEN CONSIDERED TWICE IN THIS INCIDENT. THEREFORE, PLEASE DELETE THIS MEDWATCH FROM YOUR SYSTEM.
Patient problems: Insufficient Information
MAUDE report 10640625 ↗InjuryOct 6, 2020Migration; Migration
InjurySep 29, 2020Material Integrity Problem
PATIENT WAS IMPLANTED ON THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO SCREWS WERE BACKED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10598838 ↗
Other ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES devices
- NA 03.033.001Synthes GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES265 reports
- GAMMA 3125-1180SStryker GmbH · ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page