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NA 7205321Recalls & reported problems

Smith & Nephew, Inc. · 4.5 MM ORBIT SYNOVATOR CURVED BLADES, POWER/EP-1, FOREST GREEN, CURVED LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE · Class 1

Data updated Oct 16, 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 03596010251497), received between Dec 8, 2020 and Dec 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Delivered as Unsterile Product1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionDec 8, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

    IT WAS REPORTED THAT WHEN UNPACKING THE SYNOVATOR BLADE, IT WAS FOUND TO HAVE CONTAMINATION ON THE TIP. NO CASE REPORTED, THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10972971 ↗

Other SAW, POWERED, AND ACCESSORIES devices

All SAW, POWERED, AND ACCESSORIES devices →

Sources and updates

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