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ACUFEX 013663Recalls & reported problems

Smith & Nephew, Inc. · 10 MM ENDOSCOPIC CANNULATED DRILL BIT · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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 03596010025203), received between Apr 16, 2019 and Apr 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (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

  • Degraded1

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.

  • MalfunctionApr 16, 2019Degraded

    IT WAS REPORTED A RUST ON THE DRILL BIT. NO PATIENT INJURIES OR DELAY WERE REPORTED AS THE FAILURE WAS FOUND AFTER THE CASE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8520396 ↗

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Sources and updates

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