NA 351.709SRecalls & reported problems
Synthes GmbH · 2.5MM REAMING ROD W/BALL TIP 650MM-STERILE · 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 10886982193889), received between Dec 4, 2025 and Dec 4, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
- Crack3
- Device-Device Incompatibility3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE STERILIZED/ASSEMBLED. IT WAS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720546 ↗MalfunctionDec 4, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE STERILIZED/ASSEMBLED. IT WAS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720545 ↗MalfunctionDec 4, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE STERILIZED/ASSEMBLED. IT WAS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720543 ↗
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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