AFFIXUS®HIP FRACTURE NAIL - LEFT 8146-09-380Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868039713), received between Aug 10, 2022 and Aug 10, 2022 — classified as 1 injury.

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

250 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Fracture; Fracture

  ON AN UNKNOWN DATE A PATIENT HAD AN INITIAL SURGERY. ON ANOTHER UNKNOWN DATE THE PATIENT CAME IN FOR A REVISION DUE TO AN IMPLANTED NAIL FRACTURE.

  Patient problems: Failure of Implant

  MAUDE report 15199681 ↗

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-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-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-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-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-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-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-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-0157-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
• Z-0137-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
• Z-0138-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
• Z-0167-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures
• Z-0161-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
• Z-0130-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
• 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

…and 235 more.