AFFIXUS®HIP FRACTURE NAIL ANTI-ROTATION SCREW 8145-01-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868038761), received between Jun 15, 2020 and Jun 15, 2020 — classified as 1 injury.

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.

• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL SURGERY WAS APPROXIMATELY TWO (2) MONTHS AGO. AT THE THREE (3) WEEK CHECK-UP, SURGEON WAS SATISFIED WITH FOLLOW UP FILMS. APPROXIMATELY ONE (1) MONTH POST-IMPLANTATION, OBESE PATIENT FELL AND APPARENTLY "HOBBLED" ON IT FOR FIVE (5) DAYS BEFORE BEING REMOVED. ALL IMPLANTS WERE INTACT. SURGEON IMPLANTED A TOTAL HIP BECAUSE THE LAG SCREW PENETRATED THROUGH THE FEMORAL HEAD (IE. CUT OUT).

  Patient problems: Fall; Patient Problem/Medical Problem

  MAUDE report 10153508 ↗

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-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-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-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-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-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-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-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-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
• 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-0143-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 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
• 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-0144-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures
• Z-0125-2019 · Aug 8, 2018 · Terminated
  Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures

…and 235 more.