NA 03.100.014Recalls & reported problems
Synthes GmbH · SCIATIC NERVE RETRACTOR LONG · Class 1
Data updated Oct 16, 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 10886982070630), 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 (B)(6) 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 SCIATIC NERVE RETRACTOR LONG. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619038 ↗
Other RETRACTOR devices
- Endo Paddle Retract 173046Covidien LP · RETRACTOR56 reports
- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 3104RIntegra Lifesciences Corporation · RETRACTOR1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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