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ENNOVATE SZ228RRecalls & reported problems

Aesculap AG · ENNOVATE TORQUE WRENCH HANDLE 10NM · Class 1

All models of ENNOVATE (11)

Data updated Oct 18, 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 04046964700859), received between Mar 25, 2021 and Mar 25, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Degraded1

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.

  • MalfunctionMar 25, 2021Degraded; Degraded

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SZ228R - ENNOVATE TORQUE WRENCH HANDLE 10NM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CENTRAL PROCESSING DEPARTMENT (CPD) STAFF WAS PROCESSING THE TRAY TO BE READY FOR SURGERY AND UPON INSPECTION, METAL SHAVINGS FELL OUT OF THE INSTRUMENT. INSTRUMENT HAS BEEN PULLED AND SWAPPED OUT OF THE SET WITH THE REPLACEMENTS. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11568438 ↗

Other WRENCH devices

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Sources and updates

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