Affixus® Natural Nail® 47-2486-036-40Recalls & 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 implantable rod used to hold broken bones in place. The 41 reports that name its identifier mostly describe screws backing out of position weeks after surgery, sometimes with pain and repeat surgery to reinsert or remove the hardware. The reports mention 36 injuries and no deaths, 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
- 44
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00889024505421), received between Dec 30, 2019 and Sep 9, 2026 — classified as 39 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Migration” (34 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
- Migration34
- Migration or Expulsion of Device10
- Patient Device Interaction Problem4
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
- Fracture1
- Human-Device Interface Problem1
- Mechanical Problem1
Patient problems
- Failure of Implant24
- Pain14
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions8
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Impingement1
- Needle Stick/Puncture1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Migration
It was reported that three proximal screws backed out approximately two weeks post-implantation. The surgeon monitored the condition and, as the bone had not yet healed, considered a method of re-immobilization. The patient remained under observation, follow-up surgery is being planned, the patient experienced pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50692633 ↗InjurySep 9, 2026Migration
It was reported that three proximal screws backed out approximately two weeks post-implantation. The surgeon monitored the condition and, as the bone had not yet healed, considered a method of re-immobilization. The patient remained under observation, follow-up surgery is being planned, the patient experienced pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50692617 ↗InjurySep 9, 2026Migration
It was reported that three proximal screws backed out approximately two weeks post-implantation. The surgeon monitored the condition and, as the bone had not yet healed, considered a method of re-immobilization. The patient remained under observation, follow-up surgery is being planned, the patient experienced pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50692340 ↗MalfunctionNov 17, 2025Migration; Migration
IT WAS REPORTED THAT AN INITIAL OPERATION WAS PERFORMED WITH ANN NAIL. SUBSEQUENTLY, A PROXIMAL SCREW WAS OBSERVED TO HAVE BACKED OUT APPROXIMATELY 2 WEEKS POSTOPERATIVELY. THE PATIENT WILL BE MONITORED AND NO REVISION SURGERY HAS BE PLANNED SO FAR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568232 ↗MalfunctionJul 1, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY WITH ANN NAIL SYSTEM. SUBSEQUENTLY, 42 DAYS POST IMPLANTATION, SURGEON FOUND THAT 3 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: Insufficient Information
MAUDE report 22370755 ↗InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL ORIF OF THE LEFT HUMERUS. SUBSEQUENTLY, THE SITE REPORTED NAIL PROTRUSION WITH IMPINGEMENT SYMPTOMS. THE PATIENT UNDERWENT HARDWARE REMOVAL, APPROXIMATELY 10 MONTHS POST IMPLANTATION, WITH REPAIR OF A PARTIAL ROTATOR CUFF INJURY. NO COMPLICATIONS OR ALLEGATIONS AGAINST HARDWARE WERE REPORTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Joint Impingement; Pain
MAUDE report 22169767 ↗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 21106003 ↗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 21106002 ↗InjuryAug 14, 2024Migration; Migration
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 19986243 ↗MalfunctionJul 5, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 19681751 ↗MalfunctionJun 5, 2024Migration; Migration
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL. AFTER 8 WEEKS POST-IMPLANTATION, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION AS WELL, AS NO REVISION HAS BEEN PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 19472153 ↗InjuryMar 18, 2024Migration; Migration
IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL, AFTER 8 MONTHS FROM THE INITIAL, SURGEON FOUND #1 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Pain
MAUDE report 18924483 ↗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 18118673 ↗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 18118663 ↗InjuryOct 13, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Pain
MAUDE report 17928696 ↗InjurySep 15, 2023Migration; Migration
IT WAS REPORTED THAT AFTER A YEAR POST RIGHT-SIDE IMPLANTATION SURGEON FOUND ONE OF THE SCREWS BACKED OUT FROM THE PROPER POSITION. REVISION SURGERY WAS PERFORMED FIVE MONTHS LATER TO REMOVE THE MIGRATED SCREW. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 17754167 ↗InjuryAug 30, 2023Migration; Migration
IT WAS REPORTED THAT FIVE WEEKS POST-IMPLANTATION ONE OF THE SCREWS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED 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 17648644 ↗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 17160287 ↗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 17160285 ↗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 16804711 ↗InjuryApr 25, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16804707 ↗InjuryMar 30, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16641953 ↗InjuryMar 6, 2023Migration; Migration
IT WAS REPORTED THAT THREE MONTHS POST-IMPLANTATION, THE SURGEON FOUND THAT THE TWO PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION. REVISION SURGERY IS NOT CURRENTLY PLANNED. 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 16485420 ↗InjuryFeb 3, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16290054 ↗InjurySep 29, 2022Migration; 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 15507843 ↗
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