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NA 7205308Recalls & reported problems

Smith & Nephew, Inc. · 3.5 MM CUTTER STRAIGHT BLADES, POWER/EP-1, RED, PACKAGED 6 PER BOX, STERILE · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010251367), received between Sep 8, 2018 and Sep 8, 2018 — classified as 1 malfunction.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 8, 2018Material Fragmentation

    IT WAS REPORTED A FRAGMENTATION OF THE METAL OF THE BLADES DURING PROCEDURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7858537 ↗

Other SAW, POWERED, AND ACCESSORIES devices

All SAW, POWERED, AND ACCESSORIES devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.