Affixus® Natural Nail® 110035672Recalls & reported problems
Zimmer GmbH · Class 2
All models of Affixus Natural Nail (55)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024506633), received between Nov 3, 2021 and Jun 17, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Most reported problems
Device problems
- Fracture1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2023Fracture; Fracture
IT WAS REPORTED THAT THE NAIL JIG BROKE DURING SURGERY. SURGEON HAD TO COMPLETE INSERTING PROXIMAL SCREWS FREE HAND. NO PIECE WAS LEFT IN THE PATIENT BUT A DELAY OF TWO HOURS CAUSED. THIS EVENT IS RELATED TO A MALFUNCTION THAT COULD POTENTIALLY LEAD TO A SERIOUS INJURY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, WHATEVER ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17149103 ↗MalfunctionNov 3, 2021Mechanical Jam; Mechanical Jam
INVESTIGATION RESULTS ARE NOW AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12743987 ↗
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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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