SMARTSET 85-8873Recalls & reported problems
Depuy Orthopaedics, Inc. · SMARTSET STRAIGHT REAMER 6mm · Class 1
Data updated Oct 13, 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 10603295215240), received between Jul 26, 2019 and May 9, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Corroded” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Corroded1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2023Corroded; Corroded
IT WAS REPORTED THAT THERE WAS RUST ON DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16895874 ↗MalfunctionJul 26, 2019Scratched Material; Scratched Material
IT WAS REPORTED THAT MULTIPLE SROM REAMERS WERE DAMAGED DURING A SURGERY WITH SURGEON. THE REAMERS WERE USED TO "REAM" THROUGH SOME HARDWARE LEFT IN A HIP. SINCE THE REAMERS WERE USED TO DO THIS, MANY OF THEM HAVE BEEN DAMAGED AND NEED TO BE REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8831125 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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