AFFIXUS®HIP FRACTURE NAIL 8145-11-180Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868039102), received between Apr 5, 2022 and Apr 9, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

1 FDA recall record name this device's identifier.

249 other recalls cover devices cleared under the same FDA submission (K100238); they may or may not involve this specific model.

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.

Recalls naming this device

1. Aug 7, 2017Class IITerminated

   During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.

   Z-0422-2018 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP FRACTURE SURGERY APPROXIMATELY SEVEN (7) YEARS AGO, SUBSEQUENTLY, THE PATIENT IS ABLE TO PALPATE THE LAG SCREW THROUGH THE SKIN AND WAS CAUSING THE PATIENT DISCOMFORT. THE PATIENT UNDERWENT A REVISION SURGERY ON AND UNKNOWN DATE AND ALL IMPLANTS WERE REMOVED.

  Patient problems: Discomfort

  MAUDE report 19070992 ↗
• InjuryApr 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REPAIR. THE SURGEON PUT IN A HIP NAIL WITH A ROD AND SCREW. THE PATIENT WAS REVISED DUE TO PAIN AND IMPLANT FRACTURE ELEVEN MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 14017297 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100238. One submission often covers many models, so check the product and lot details in each record.

• Z-0451-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0450-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedu
• Z-0454-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0448-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramed
• Z-0449-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramed
• Z-0452-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0453-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0447-2019 · Oct 2, 2018 · Terminated
  Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullar
• Z-0134-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
• Z-0156-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
• Z-0148-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
• Z-0128-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fractures
• Z-0165-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
• Z-0164-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
• Z-0129-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures

…and 234 more.