AFFIXUS®HIP FRACTURE NAIL LAG SCREW 8145-10-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00887868038983), received between Apr 27, 2022 and Mar 21, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (11 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2023Manufacturing, Packaging or Shipping Problem; Packaging Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582953 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14223413 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14223108 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14223042 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222975 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222946 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222945 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222907 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222651 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222523 ↗
• MalfunctionApr 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THEY FOUND AIR BUBBLES IN THE SEALING AREA OF THE PACKAGE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222446 ↗

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-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-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-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-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-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-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-0147-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
• Z-0132-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fractures
• Z-0149-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
• Z-0131-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
• Z-0169-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 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-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

…and 235 more.