EVOS 72434746Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556637753), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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.

• MalfunctionJun 28, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT PATIENT HAD A TRIMALLEOLAR FRACTURE FIXATION, FIXED WITH EVOS. PROBLEM OCCURRED WITH THE FIXATION OF THE MEDIAL MALLEOLUS. REDUCED WITH A K-WIRE, INSERTED 2.5 DRILL AS PER OPERATIVE TECHNIQUE FOR A 4.7 CANCELLOUS SCREW, THE SCREW WOULD NOT ENGAGE OR ADVANCE INTO THE DRILLED HOLE. DELAY FROM (30 MINUTES - 1 HOUR) REPORTED. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED. PATIENT IS 40 YEARS OLD, NO PRE-EXISITING CO-MORBIDITIES AND HAS GOOD BONE QUALITY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8742940 ↗

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.