ARTHROGARDE 72200097Recalls & reported problems
Smith & Nephew, Inc. · 5.0 MM CANNULATED OBTURATOR WITH BLACK DELRIN HANDLE · Class 1
Data updated Oct 16, 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 03596010542458), received between May 13, 2022 and Nov 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Flaked” (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
- Flaked1
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2022Sharp Edges; Sharp Edges
IT WAS REPORTED THAT DURING SET-UP (MDRD), IT WAS NOTICED THAT A CANNULATED OBTURATOR HAD ITS TIP DAMAGED, ITS SHARPED. A NON-SIGNIFICANT DELAY WAS REPORTED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15724996 ↗MalfunctionMay 13, 2022Flaked; Flaked
IT WAS REPORTED THAT DURING SET UP OF A DEMO INVENTORY, THE BLACK RESIDUE OF THE CANNULATED OBTURATOR WAS FLAKING CAUSING A CONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14395601 ↗
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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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