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NA 72202992Recalls & reported problems

Smith & Nephew, Inc. · 17 MM SUTURE WASHER STERILE. BOX OF 1 · Class 2

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 00885554017595), received between Dec 26, 2017 and Dec 26, 2017 — classified as 1 malfunction.

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

  • Break1

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.

  • MalfunctionDec 26, 2017Break

    IT WAS REPORTED THAT WHEN TENSION WAS PLACED ON THE GRAFT, THE SUTURES BROKE. NO PATIENT INJURIES WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7146094 ↗

Other WASHER, BOLT NUT devices

All WASHER, BOLT NUT devices →

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