EVOS 71175044Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556636435), received between May 11, 2021 and May 3, 2024 — classified as 4 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K162078); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PLATE PROCEDURE, ONE SIDE OF AN EVOS 2.5MM COMP/NEUTRAL DRILL GUIDE FELL OUT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240032 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT, A EVOS 2.5MM COMP/NEUTRAL DRILL GUIDE HAS BROKEN AWAY FROM MAIN INSTRUMENT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760504 ↗
• MalfunctionJun 22, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, THE EVOS 2.5MM COMP/NEUTRAL DRILL GUIDE FOR COMPRESSION SLOT WON'T MOVE. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038827 ↗
• MalfunctionMay 11, 2021Unstable; Incomplete or Inadequate Connection; Unstable; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING INSPECTION, THE SPRING IN A EVOS 2.5MM COMP/NEUTRAL DRILL GUIDE WAS NOTICED TO BE LOOSENED, RESULTING IN AN UNSTABLE CONDITION OF THE CONSTRUCT. NO CASE INVOLVED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810086 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078. 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.