AFFIXUSHIP FRACTURE NAIL - RIGHTRecalls & reported problems across all models

We found 39 models of AFFIXUSHIP FRACTURE NAIL - RIGHT by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2021 and Jan 17, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

37 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 - RIGHT 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, 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-0484-2018 · Root cause: Process change control · Recall details · FDA record ↗

2. 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-0483-2018 · Root cause: Process change control · Recall details · FDA record ↗

3. 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-0482-2018 · Root cause: Process change control · Recall details · FDA record ↗

4. 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-0481-2018 · Root cause: Process change control · Recall details · FDA record ↗

5. 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-0480-2018 · Root cause: Process change control · Recall details · FDA record ↗

6. 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-0479-2018 · Root cause: Process change control · Recall details · FDA record ↗

7. 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-0478-2018 · Root cause: Process change control · Recall details · FDA record ↗

8. 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-0477-2018 · Root cause: Process change control · Recall details · FDA record ↗

9. 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-0476-2018 · Root cause: Process change control · Recall details · FDA record ↗

10. 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-0475-2018 · Root cause: Process change control · Recall details · FDA record ↗

11. 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-0474-2018 · Root cause: Process change control · Recall details · FDA record ↗

12. 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-0473-2018 · Root cause: Process change control · Recall details · FDA record ↗

13. 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-0472-2018 · Root cause: Process change control · Recall details · FDA record ↗

14. 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-0471-2018 · Root cause: Process change control · Recall details · FDA record ↗

15. 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-0470-2018 · Root cause: Process change control · Recall details · FDA record ↗

16. 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-0469-2018 · Root cause: Process change control · Recall details · FDA record ↗

17. 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-0468-2018 · Root cause: Process change control · Recall details · FDA record ↗

18. 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-0467-2018 · Root cause: Process change control · Recall details · FDA record ↗

19. 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-0466-2018 · Root cause: Process change control · Recall details · FDA record ↗

20. 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-0465-2018 · Root cause: Process change control · Recall details · FDA record ↗

21. 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-0464-2018 · Root cause: Process change control · Recall details · FDA record ↗

22. 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-0463-2018 · Root cause: Process change control · Recall details · FDA record ↗

23. 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-0462-2018 · Root cause: Process change control · Recall details · FDA record ↗

24. 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-0461-2018 · Root cause: Process change control · Recall details · FDA record ↗

25. 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-0460-2018 · Root cause: Process change control · Recall details · FDA record ↗

26. 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-0459-2018 · Root cause: Process change control · Recall details · FDA record ↗

27. 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-0458-2018 · Root cause: Process change control · Recall details · FDA record ↗

28. 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-0457-2018 · Root cause: Process change control · Recall details · FDA record ↗

29. 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-0456-2018 · Root cause: Process change control · Recall details · FDA record ↗

30. 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-0455-2018 · Root cause: Process change control · Recall details · FDA record ↗

…and 7 older recalls, listed on each model's page.

Most reported AFFIXUSHIP FRACTURE NAIL - RIGHT problems

AFFIXUSHIP FRACTURE NAIL - RIGHT models

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

• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-09-340

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-380

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-280

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-380

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall1 report
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-09-260

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-09-320

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-09-360

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-09-400

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-09-420

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-09-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-09-460

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-11-300

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-11-380

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-11-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-11-460

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-13-260

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-13-320

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-260

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-300

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-320

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-340

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-360

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-400

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-420

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-09-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-260

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-300

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-320

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-340

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-360

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-400

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-420

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-11-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-13-280

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-13-300

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-13-440

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8145-13-460

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 recall0 reports
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-11-360

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 report
• AFFIXUS®HIP FRACTURE NAIL - RIGHT 8143-11-400

  ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
  1 report

Recent AFFIXUSHIP FRACTURE NAIL - RIGHT adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJan 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP FRACTURE FIXATION PROCEDURE. SUBSEQUENTLY, THREE (3) MONTHS POST-IMPLANTATION, THE PATIENT PRESENTED WITH PAIN AND MOBILITY DIFFICULTIES. DIAGNOSTIC IMAGES REVEALED A FRACTURE OF THE IMPLANTED FEMORAL FIXATION NAIL. THE PATIENT UNDERWENT REVISION SURGERY OF THE AFFECTED NAIL SIX (6) MONTHS POST-IMPLANTATION WITHOUT REPORTED COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 18528354 ↗
• MalfunctionJan 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE NAIL BROKE APPROXIMATELY FOUR MONTHS POST-INITIAL IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18436484 ↗
• InjuryJun 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL SURGERY APPROXIMATELY 2 YEARS AGO, SHE HAS SINCE HAD A RIGHT BROKEN AFFIXUS HIP FRACTURE NAIL WHICH HAD TO BE REMOVED AND THE FRACTURE FIXED WITH A SYNTHES TROCHANTERIC HOOK PLATE. THE ORIGINAL FRACTURE WAS A SUB TROCHANTERIC FRACTURE EXTENDING DISTALLY TOWARDS THE MID SHAFT. A CABLE CAN BE SEEN ON THE X-RAY AT THE TIME OF REMOVING THE NAIL SHOWING SOME CALLOUS FORMATION AROUND THE MID TO PROXIMAL SECTION OF BONE AND LOOKS TO HAVE HEALED. THE NAIL HAD BROKEN AT THE CIRCLE SECTION WHERE THE LAG SCREW GOES THROUGH THE NAIL AND INTO THE FEMORAL NECK AND ACETABULA HEAD. THE FEMUR HAS FRACTURED FROM THE LATERAL SIDE APPROXIMATELY 8CM BELOW THE GREATER TROCHANTER AND EXTENDED MEDIALLY TOWARDS THE LESSER TROCHANTER AND INFERIOR FEMORAL NECK. THERE WAS NO DISCERNABLE REASON AS TO WHY THE NAIL HAD BROKEN. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 14743667 ↗
• InjuryApr 8, 2022Fracture; Fracture

  NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 14052340 ↗
• MalfunctionNov 19, 2021Mechanical Jam; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844258 ↗
• InjuryFeb 2, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FRACTURE OF THE AFFIXUS NAIL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 11265856 ↗

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