NA 03.211.016Recalls & reported problems
Synthes GmbH · CANNULATED REAMER DISTAL/16MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982076113), received between Aug 27, 2024 and Sep 9, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (3 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
- Failure to Cut3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2025Failure to Cut; Failure to Cut
IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE CUP AND CONE REAMERS WERE NO LONGER SHARP FOR MTP FUSION JOINT PREP.
Patient problems: Insufficient Information
MAUDE report 23006142 ↗MalfunctionAug 27, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON AUGUST 1, 2024, THE DEVICES WERE DULL. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER DISTAL/16MM. THIS IS REPORT 10 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20079824 ↗MalfunctionAug 27, 2024Failure to Cut; Failure to Cut
IT WAS REPORTED THAT ON AUGUST 1, 2024, THE DEVICES WERE DULL. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) CANNULATED REAMER DISTAL/16MM THIS IS REPORT 5 OF 10 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20078947 ↗
Other REAMER devices
- QUICKSET 2440-00-551Depuy (Ireland) · REAMER1,150 reports
- QUICKSET 2440-00-549Depuy (Ireland) · REAMER1,113 reports
- QUICKSET 2440-00-553Depuy (Ireland) · REAMER1,105 reports
- QUICKSET 2440-00-547Depuy (Ireland) · REAMER1,073 reports
- QUICKSET 2440-00-555Depuy (Ireland) · REAMER1,065 reports
- QUICKSET 2440-00-557Depuy (Ireland) · REAMER1,031 reports
- QUICKSET 2440-00-545Depuy (Ireland) · REAMER947 reports
- QUICKSET 2440-00-552Depuy (Ireland) · REAMER888 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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