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NA 03.615.360Recalls & reported problems

Synthes GmbH · RETRACTOR BLADE 60MM CRANIAL/CAUDAL-LEFT · 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 10705034715766), received between Dec 31, 2020 and Dec 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 Integrity Problem1

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 31, 2020Material Integrity Problem; Material Integrity Problem

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN DATE, AFTER A PROCEDURE, IT WAS NOTICED THAT PART OF THE RETRACTOR BLADE WAS BROKEN. THE PATIENT WAS SENT FOR X-RAYS A DAY AFTER THE PROCEDURE AND NO FRAGMENTS WERE VISIBLE IN THE X-RAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: BLADE CRANIAL/CAUDAL R L60 ( PART NUMBER 03.615.460, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) RETRACTOR BLADE 60MM CRANIAL/CAUDAL-LEFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11101208 ↗

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.