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NA 397.213Recalls & reported problems

Synthes GmbH · 2.0MM CANNULA & OBTURATOR · Class 1

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 10887587041216), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

  • Device-Device Incompatibility1

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.

  • MalfunctionAug 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SET SCREW ON THE 2.0 CHEEK BLADE RETRACTOR DID NOT ENGAGE WITH THE RETRACTOR. IT NEEDED TO BE FIXED FOR ITEM TO WORK PROPERLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE CANNULA+OBTURATOR 2. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15148992 ↗

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Sources and updates

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