NA 03.043.003Recalls & reported problems
Synthes GmbH · PROTECTION SLEEVE / SHORT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982297136), received between Feb 5, 2025 and Oct 3, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (5 reports).
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
- Device-Device Incompatibility5
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
BOTH TROCARS AND HANDLE ARE DAMAGED; DON'T FIT ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23213870 ↗MalfunctionOct 3, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
BOTH TROCARS AND HANDLE ARE DAMAGED; DON'T FIT ANYMORE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23213869 ↗MalfunctionAug 7, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE SLEEVES DO NOT FIT IN HANDLES AND GET STUCK. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737433 ↗MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT IT IS NOT POSSIBLE TO DISCONNECT DEVICE FROM ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060420 ↗MalfunctionFeb 5, 2025Device-Device Incompatibility; Device-Device Incompatibility
ORTHOKIT COMPLAINT: AT THE TNA TIBIANAGEL IN COESFELD, THIS COMPONENT CANNOT BE ASSEMBLED SINCE THE START OF TESTING. PROBLEM: THE TISSUE PROTECTION SLEEVE CANNOT BE PUSHED OVER OR DOES NOT LOCK IN THE HANDLE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312335 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
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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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