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NA 03.401.054Recalls & reported problems

Synthes GmbH · RING RETRACTOR/DELTA-SHAPED · 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 10886982079770), received between Apr 26, 2022 and Apr 26, 2022 — 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 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.

  • MalfunctionApr 26, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE RING RETRACTOR DELTA-SHAPED IN QUESTION HAD BEEN BROKEN WHEN THE RING RETRACTOR WAS DELIVERED TO THE HOSPITAL. THE RING RETRACTOR WAS PURCHASED LAST YEAR. THE HOSPITAL REQUESTED TO RETURN THE BROKEN RING RETRACTOR AND DELIVER A NEW RING RETRACTOR. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) RING RETRACTOR DELTA-SHAPED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14208795 ↗

Other RETRACTOR devices

All RETRACTOR devices →

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