NA 232418Recalls & reported problems
Medos International Sàrl · FULLY FLUTED REAMER, STERILE 40 - 130mm (Plus or Minus 5 Percent) 8.5mm · 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 10886705011308), received between Dec 6, 2019 and Dec 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Dull, Blunt” (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.
Most reported problems
Device problems
- Dull, Blunt1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2019Dull, Blunt
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE SURGEON FOUND THAT THE SALES REP'S RESTORE FULL FLUTE REAMER 7MM, RESTORE FULL FLUTE REAMER 7.5MM, RESTORE FULL FLUTE REAMER 8MM, RESTORE FULL FLUTE REAMER 8.5MM, RESTORE FULL FLUTE REAMER 9MM, RESTORE FULL FLUTE REAMER 9.5MM, AND RESTORE FULL FLUTE REAMER 10MM ARE ALL DULL. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICES WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION OR LOT NUMBERS FOR THE DEVICES. THE DEVICES WILL BE RETURNING FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9433424 ↗
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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