Affixus® Natural Nail® 47-2486-038-40Recalls & 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 fractures inside long bones. The 53 reports mostly describe screws backing out or shifting out of position after surgery, sometimes with pain and, in some cases, a second operation to reinsert the screws. There are 41 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
- 53
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00889024505438), received between Jun 26, 2020 and May 20, 2026 — classified as 41 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Migration” (40 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
- Migration40
- Migration or Expulsion of Device18
- Patient Device Interaction Problem7
- Loosening of Implant Not Related to Bone-Ingrowth3
- Adverse Event Without Identified Device or Use Problem1
- Device Slipped1
- Device-Device Incompatibility1
Patient problems
- Failure of Implant29
- Pain14
- Insufficient Information11
- No Clinical Signs, Symptoms or Conditions11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Unspecified Tissue Injury3
- No Code Available1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
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 25237096 ↗MalfunctionFeb 5, 2026Migration
IT WAS REPORTED THAT ONE PROXIMAL SCREW BACKED OUT APPROXIMATELY 2 MONTHS POSTOPERATIVELY FOLLOWING AN INTRAMEDULLARY NAILING PROCEDURE. THE PATIENT WAS MONITORED, AND NO REVISION WAS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274676 ↗MalfunctionOct 31, 2025Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23437333 ↗InjuryJan 8, 2025Migration; Migration
IT WAS REPORTED THAT AN ANN NAIL SURGERY WAS PERFORMED. AFTER 1 MONTH 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. IN THE REVISION SURGERY, THE SCREWS THAT HAD COME LOOSE WERE REINSERTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 21106005 ↗InjuryOct 24, 2024Migration; Migration
IT WAS REPORTED THAT AN INITIAL OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM AND AFTER 3 WEEKS, SURGEON FOUND TWO OF THE PROXIMAL SCREWS WERE 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. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 20522091 ↗InjuryOct 24, 2024Migration; Migration
IT WAS REPORTED THAT AN INITIAL OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM AND AFTER 3 WEEKS, SURGEON FOUND TWO OF THE PROXIMAL SCREWS WERE 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. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 20522078 ↗MalfunctionOct 8, 2024Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 20398421 ↗InjuryAug 27, 2024Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 20077723 ↗InjuryAug 22, 2024Migration; Migration
DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 20038826 ↗InjuryAug 15, 2024Migration; Migration
IT WAS REPORTED THAT AFTER 2 MONTHS FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT THE #1 AND #3 PROXIMAL SCREWS HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREWS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19994475 ↗InjuryJun 20, 2024Migration; Migration
IT WAS REPORTED PATIENT UNDERWENT REVISION APPROXIMATELY 4 WEEKS FROM THE INITIAL SURGERY, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION WAS PERFORMED TO REMOVE THE MIGRATED SCREW. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19579275 ↗InjuryJan 30, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 18606745 ↗InjuryJan 5, 2024Migration; Migration
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN APPROXIMATELY 1 MONTH AGO. AFTER 4 DAYS FROM THE INITIAL, SURGEON FOUND ALL PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. NO REOPERATION DATE HAS BEEN SET, BUT THE ANN WILL BE REMOVED, AND THE RSA WILL BE PERFORMED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 18455903 ↗MalfunctionDec 21, 2023Migration; Migration
IT WAS REPORTED THAT AFTER 2 WEEKS FROM THE INITIAL PROCEDURE, SURGEON FOUND THAT THE 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. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. 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 18377002 ↗MalfunctionDec 19, 2023Migration; Migration
DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 18357514 ↗InjuryDec 11, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO PROXIMAL SCREWS THAT 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 18307484 ↗InjuryNov 13, 2023Migration; Migration
IT WAS REPORTED THERE WAS A REVISION SURGERY 1 MONTH AFTER IMPLANTATION DUE TO ALL PROXIMAL SCREWS HAVING 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; Pain
MAUDE report 18118696 ↗InjuryJun 22, 2023Migration; Migration
IT WAS REPORTED THAT FOUR (4) WEEKS AFTER IMPLANTATION OF SHOULDER NAIL, ONE OF THE PROXIMAL SCREWS HAS BACKED OUT FROM PROPER POSITION. IT IS NOT KNOWN WHICH ONE EXACTLY BACKED OUT. NO REVISION IS PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17179746 ↗InjuryJun 22, 2023Migration; Migration
IT WAS REPORTED THAT FOUR (4) WEEKS AFTER IMPLANTATION OF SHOULDER NAIL, ONE OF THE PROXIMAL SCREWS HAS BACKED OUT FROM PROPER POSITION. IT IS NOT KNOWN WHICH ONE EXACTLY BACKED OUT. NO REVISION IS PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17179743 ↗InjuryJun 20, 2023Migration; Migration
IT WAS REPORTED THAT THE TWO PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION ABOUT FOUR (4) MONTHS AFTER THE INITIAL SURGERY. THE SURGEON WILL KEEP AN EYE ON THE PATIENT'S CONDITION. NO REVISION WILL BE PLANNED SO FAR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 17160297 ↗InjuryJun 13, 2023Migration; Migration
IT WAS REPORTED THAT AFTER TWO WEEKS FROM THE INITIAL SURGERY, TWO PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION. NO CONSEQUENCES OR IMPACT TO THE PATIENT. 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 17115989 ↗InjuryApr 26, 2023Migration; Migration
IT WAS REPORTED THAT ONE MONTH AFTER INITIAL RIGHT HUMERAL NAIL IMPLANTATION ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM ITS PROPER POSITION. NO INTERVENTION IS PLANNED AT THIS TIME. 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 16813090 ↗InjuryApr 25, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16804865 ↗InjuryApr 25, 2023Migration; Migration
IT WAS REPORTED THAT FOUR MONTHS AFTER INITIAL LEFT HUMERAL NAIL IMPLANTATION ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM ITS PROPER POSITION. NO INTERVENTION IS PLANNED AT THIS TIME. 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 16804710 ↗InjuryApr 6, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16687531 ↗
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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