NA 03.033.010Recalls & reported problems
Synthes GmbH · 12/4.6MM TROCAR FOR REAMER PROTECTION TUBE · 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 10886982272881), received between Jul 24, 2025 and Jul 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
- Material Deformation1
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.
MalfunctionJul 24, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DRIVER HEAD STARTED TO STRIP, INSERT FOR TROCAR/GUIDE PIN BECAME MISSHAPED AND DIDN'T FIT INTO THE PROTECTION SLEEVE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF SURGERY WAS DELAYED DUE TO THE REPORTED EVENT AND IF PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22589050 ↗
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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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