EVOS 72434740Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556637722), received between Jul 1, 2021 and Jul 1, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 other recall cover devices cleared under the same FDA submission (K162078, K172262, 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.

• InjuryJul 1, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, A EVOS 4.7MM X 40MM OSTEOPENIA SCREW PARTIALLY THREADED (CASE-(B)(4)) AND A EVOS 4.7MM X 42MM OSTEOPENIA SCREW PARTIALLY THREADED (CASE-(B)(4)) WERE NOT SUITABLE TO FIX ALL MEDIAL MALLEOLUS FRACTURES AND DESTROYED THE SMALLER FRAGMENTS OF THE BONE. HE STATES THAT THE THREAD IS DIFFICULT TO START BECAUSE IT IS NOT SELF TAPPING, AND THAT HE PREFERRED THE OLD SIZED 4.0MM CANCELLOUS SCREWS FROM OUR PREVIOUS ORIF SET TC-100. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. CURRENT STATE OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Bone Shedding Debris

  MAUDE report 12101214 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078, K172262, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.

• Z-0265-2022 · Oct 25, 2021 · Open, Classified
  Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.