Affixus® Natural Nail® 47-2486-046-40Recalls & 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 intramedullary rod used to fix fractures, most often in the upper arm bone. The 55 adverse event reports mostly describe screws backing out or shifting out of place after surgery, sometimes causing pain and requiring a second operation to remove them. No deaths were reported; 51 injuries and 4 malfunctions were. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00889024505476), received between Jan 17, 2020 and Jun 2, 2026 — classified as 51 injuries, 4 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 Problem11
- Appropriate Device Problem Term/Code Not Available2
- Device-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Separation Problem1
Patient problems
- Failure of Implant30
- Insufficient Information16
- Pain11
- No Clinical Signs, Symptoms or Conditions9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Code Available2
- Impaired Healing1
- No Information1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY AND SUBSEQUENTLY REQUIRED A REOPERATION APPROXIMATELY 3 MONTHS POST-IMPLANTATION DUE TO PROXIMAL SCREW BACKOUT ASSOCIATED WITH PAIN. DURING FOLLOW-UP APPROXIMATELY 3 MONTHS AFTER THE INITIAL PROCEDURE, THE SURGEON NOTED THAT PROXIMAL SCREWS IN POSITIONS #1 AND #3 HAD BACKED OUT OF THEIR PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 25363413 ↗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 24229172 ↗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 23497512 ↗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 22011190 ↗InjuryApr 28, 2025Migration; Migration
IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE AFFIXUS HUMERAL NAIL. SUBSEQUENTLY, APPROXIMATELY 4 MONTHS POST IMPLANTATION, UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF ONE OF THE SCREWS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 21920474 ↗InjuryApr 21, 2025Migration; Migration
NO ADDITIONAL EVENT INFORMATION.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 21875727 ↗InjuryMar 7, 2025Migration; Migration
IT WAS REPORTED THAT A PATIENT HAD A CLOSED REDUCTION AND OSTEOSYNTHESIS WITH AN ENDOMEDULLARY NAIL OF THE RIGHT HUMERUS. SUBSEQUENTLY, 70 DAYS LATER, THE PATIENT PRESENTED WITH ANTEROEXTERNAL PAIN AND FIRST FINGER PARESTHESIA. IT WAS CONFIRMED RADIOGRAPHICALLY THAT ONE OF THE PROXIMAL SCREWS HAD MIGRATED. AND UNDERWENT A REVISION, THE MIGRATED SCREW WAS EXPLANTED WITHOUT COMPLICATIONS. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain; Paresthesia
MAUDE report 21548629 ↗InjuryOct 28, 2024Migration; Migration
IT WAS REPORTED THAT AN ANN NAIL SURGERY WAS PERFORMED AND AFTER ONE MONTH FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT A PROXIMAL SCREW HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Pain
MAUDE report 20547302 ↗InjurySep 10, 2024Migration; Migration
MalfunctionSep 3, 2024Migration; Migration
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 20124065 ↗InjuryMar 30, 2023Migration; Migration
IT WAS REPORTED THAT 4 WEEKS POST-IMPLANTATION, IT WAS CONFIRMED BY X-RAYS THAT THE LAG SCREW WAS SLIDING TO OUTER SIDE. 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 16641950 ↗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 16406647 ↗InjuryFeb 21, 2023Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 16406644 ↗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 16290046 ↗InjuryJan 10, 2023Migration; Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY. 14 DAYS POST-OP, TWO PROXIMAL SCREWS WERE FOUND TO HAVE MIGRATED, AND IMPAIRED HEALING OF THE FRACTURE WAS OBSERVED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 16129092 ↗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 16119999 ↗InjuryNov 16, 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 15803993 ↗InjuryOct 18, 2022Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO SCREW MIGRATION APPROXIMATELY ONE 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
MAUDE report 15623650 ↗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 15409403 ↗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 15409402 ↗InjuryAug 2, 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 15145268 ↗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 15014040 ↗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 14869481 ↗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 14601615 ↗InjuryMay 12, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A PROXIMAL SCREW MIGRATION WAS CONFIRMED THROUGH X-RAY 3.5 MONTHS AFTER IMPLANTATION SURGERY. IT WAS ALSO REPORTED THAT PATIENT HAS SHOULDER PAIN AND THE PROXIMAL SCREW HAD TO BE REMOVED. NO FURTHER OUTCOME REPORTED. INVESTIGATION RESULTS ARE NOW AVAILABLE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 14370597 ↗
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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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