NA 03.100.111Recalls & reported problems
Synthes GmbH · ALUMINUM SPOON RETRACTOR MEDIUM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982071095), received between Dec 6, 2021 and Jan 18, 2024 — classified as 2 malfunctions.
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
- Crack1
- Device-Device Incompatibility1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2024Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 2, 2024, THE EDGE OF THE INSTRUMENT HAS CHIPPED AND WAS UNSAFE TO USE DUE TO THE SHARP. THIS WAS IDENTIFIED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ALUMINUM SPOON RETRACTOR MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18533820 ↗MalfunctionDec 6, 2021Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, UNABLE TO STERILIZE/ASSEMBLE THE MALLEABLE RETRACTOR. CHIPPING AND CRACKING ON INSTRUMENTS. UNABLE TO USE. THIS COMPLAINT INVOLVES TEN(10) DEVICES. THIS REPORT IS FOR (1) ALUMINUM SPOON RETRACTOR MEDIUM. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12938836 ↗
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- 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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