EVOS 72402440NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556445945), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 injury.

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

2 other recalls cover devices cleared under the same FDA submission (K140814, K210837, K213126); 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.

• InjuryApr 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PROXIMAL TIBIAL OSTEOSYNTHESIS, ONCE THE BONE HAD BEEN DRILLED AND AFTER MEASURING THE DEPTH OF THE HOLE, THE EVOS 2.4MM X 40MM CTX SCR T7 S-T WAS INSERTED THROUGH ONE OF THE HOLES IN THE PLATE. THE SCREW ENTERED WITHOUT ANY INCONVENIENCE, THEN WITH THE SCREWDRIVER IT WAS PROCEEDED TO FINISH INSERTING AND SECURING THE SCREW; HOWEVER, IT WAS EVIDENT THAT THE SCREW HEAD BROKE, THUS LEAVING THE SCREW BODY INSIDE THE PLATE. IT IS UNKNOWN IF THE BROKEN PART IS STILL IN THE PATIENT OR IF IT WAS RETRIEVED FROM THE BONE. THERE WAS NO SIGNIFICANT DELAY AND A SMITH AND NEPHEW BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736161 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140814, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-2945-2020 · Aug 24, 2020 · Terminated
  EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and s
• Z-0408-2018 · Nov 29, 2017 · Terminated
  smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from