NA 03.100.013Recalls & reported problems
Synthes GmbH · SCIATIC NERVE RETRACTOR · 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 10886982070623), received between Jan 31, 2024 and Jan 31, 2024 — 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.
Reports received per month
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.
MalfunctionJan 31, 2024Break; Break
IT WAS REPORTED THAT ON JAN 17, 2024 ALL ITEMS WERE BROKEN, DAMAGED, AND/OR HAD RUBBER FALLING OFF. SURFACES ARE DELAMINATING WHICH CAUSES ISSUES DURING SANITATION. THERE WAS NO INVOLVEMENT OF ANY OPERATIONS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1SCIATIC NERVE RETRACTOR THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619026 ↗
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- Omni-Tract® 10269Integra Lifesciences Corporation · RETRACTOR1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.