FMS Screw 4.5mm JHEX4555Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842188107184), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 injury.

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

4 other recalls cover devices cleared under the same FDA submission (K112794); 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 16, 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.

• InjurySep 17, 2020Fracture; Unintended Collision; Fracture; Unintended Collision

  A TRIMED SALES REP LOCATED IN THE UNITED STATES REPORTED ON (B)(6) 2020 THAT A ACREW (JHEX4555) HAD BROKEN IN THE PATIENT. THE PATIENT STATED THAT WHILE PLAYING BASKETBALL HE FELL AND BROKE HIS TOE ALONG WITH THE SCREW THAT WAS IMPLANTED 2 YEARS PRIOR, X-RAY IMAGES WERE TAKEN TO CONFIRM THAT THE TOE AND SCREW HAD BOTH BROKEN. THE SCREW WAS ORIGINALLY IMPLANTED ON (B)(6) 2018, AND WAS REMOVED ON (B)(6) 2020. THESE SCREWS ARE DESIGNED TO STAY IN THE PATIENT FOREVER. AFTER, THE REMOVAL OF THE SCREW A NEW PLATE AND SCREWS WERE PLACED ON THE BONE TO ACHIEVE FIXATION OF THE NEW BREAK. THE SURGEON REPORTED THAT THIS DID NOT CAUSE THE PATIENT ANY FURTHER HARM. AS OF (B)(6) 2020, THE PATIENT IS HEALING WELL.

  Patient problems: Bone Fracture(s)

  MAUDE report 10550707 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112794. One submission often covers many models, so check the product and lot details in each record.

• Z-2263-2018 · Apr 13, 2018 · Terminated
  Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
• Z-2262-2018 · Apr 13, 2018 · Terminated
  Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
• Z-2265-2018 · Apr 13, 2018 · Terminated
  Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
• Z-2264-2018 · Apr 13, 2018 · Terminated
  Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x1