AFFIXUSHIP FRACTURE NAILRecalls & reported problems across all models

We found 4 models of AFFIXUSHIP FRACTURE NAIL by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2020 and Apr 9, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

4 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

AFFIXUSHIP FRACTURE NAIL recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 7, 2017Terminated

   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-0423-2018 · Root cause: Process change control · Recall details · FDA record ↗

2. Aug 7, 2017Terminated

   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 ↗

3. Aug 7, 2017Terminated

   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-0421-2018 · Root cause: Process change control · Recall details · FDA record ↗

4. Aug 7, 2017Terminated

   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-0420-2018 · Root cause: Process change control · Recall details · FDA record ↗

Most reported AFFIXUSHIP FRACTURE NAIL problems

AFFIXUSHIP FRACTURE NAIL models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AFFIXUS®HIP FRACTURE NAIL 8145-11-180

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall2 reports
• AFFIXUS®HIP FRACTURE NAIL 8143-09-180

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL 8143-11-180

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL 8145-09-180

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report

Recent AFFIXUSHIP FRACTURE NAIL adverse event reports

The 5 most recent reports across all models, 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 ↗
• InjuryOct 25, 2022Fracture; Fracture

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NAIL FRACTURE. THE END BROKEN NAIL COULD NOT BE REMOVED. IT REMAINS IN PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Foreign Body Reaction

  MAUDE report 15665731 ↗
• 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 ↗
• InjuryFeb 10, 2022Fracture; Fracture

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

  Patient problems: Failure of Implant; Impaired Healing

  MAUDE report 13509705 ↗
• 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 10153512 ↗

Other Biomet Orthopedics, LLC products

• AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
• AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
• Compress Device71 models · 99 reports · 22 recalls
• Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
• Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
• Vanguard Knee System147 models · 306 reports · 13 recalls
• STAGEONE17 models · 0 reports · 18 recalls
• StageOne Select15 models · 2 reports · 15 recalls