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NOVOCART FR660SURecalls & reported problems

Aesculap AG · ACT DISPOSABLE TREPHINE D4MM W/EJECTOR · 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 04046963565992), received between Feb 11, 2021 and Feb 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 Twisted/Bent1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionFeb 11, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FR660SU-ACT DISPOSABLE TREPHINE D4MM W/EJECTOR ACCORDING TO THE COMPLAINANT, DURING SURGERY ONE OF THE TREPINE WAS BENT DUE TO SOLID BONE. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 11314477 ↗

Other TREPHINE devices

All TREPHINE devices →

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