Affixus® Natural Nail® 47-2496-260-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00889024506022), received between Apr 1, 2022 and Sep 15, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration” (2 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  A journal article was obtained on 10-Mar-2026 that reported a retrospective study from the United States. The purpose of the study was to describe a novel technique for treatment of this unique patient population along with its risk of complications and reinfection in patients undergoing staged revision shoulder arthroplasty. The study reviewed 17 patients and 18 shoulders (1 bilateral) between January 2019 and December 2023 who underwent revision for suspected periprosthetic joint infection with proximal humeral bone loss noted preoperatively or at the time of surgery. After removal of the previous implants, a cement spacer was implanted using a OsteoRemedies prefabricated antibiotic humeral head, a Steinmann pin, and a Zimmer Biomet straight humeral nail, and unspecified antibiotic cement to connect the pieces together. The spacer was press-fit into the humeral canal. Second stage reimplantation was considered in cases once patients had completed at least 6 weeks of antibiotics, they had negative inflammatory labs and there was no evidence of wound erythema or drainage. The mean age at the time of spacer placement was 63.6 ± 7.4 years, with an average follow-up of 22.8 ± 16.0 mon

  Patient problems: Pain

  MAUDE report 50773045 ↗
• InjuryApr 28, 2025Separation Problem; Separation Problem

  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 21920442 ↗
• InjuryAug 27, 2024Separation Problem; Separation Problem

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20077747 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19539197 ↗
• InjuryOct 25, 2022Migration or Expulsion of Device; Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO MIGRATION OF THE SCREW.

  Patient problems: Failure of Implant

  MAUDE report 15665215 ↗
• InjurySep 14, 2022Migration; Migration

  IT WAS REPORTED THAT 9 MONTHS AFTER INITIAL OP, A PROXIMAL SCREW WAS FOUND TO BE BACKED OUT FROM THE PROPER POSITION. PATIENT UNDERWENT REVISION SURGERY WHERE ONLY THE MIGRATED SCREW WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417892 ↗
• InjuryApr 1, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO MIGRATION. SCREW TOGGLED OUT OF THE NAIL, EVEN WITH THE CORE LOCK THAT WAS LOCKED DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. INVESTIGATION RESULTS ARE NOW AVAILABLE. AS PART OF THE INVESTIGATION IT WAS DETERMINED THAT THE NAIL HERE REPORTED, MAY ALSO BE A CONTRIBUTING FACTOR FOR THE REPORTED EVENT. THEREFORE IT HAS BEEN MOVED FROM CONCOMITANT TO MAIN DEVICE AND THIS INITIAL AND FINAL COMBINED REPORT IS BEING FILED.

  Patient problems: Failure of Implant

  MAUDE report 13976367 ↗