NA 7204895Recalls & reported problems
Smith & Nephew, Inc. · CANN 5.5 WO/HOLES LTX FREE ORANGE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010250667), received between Aug 10, 2022 and Aug 10, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Fragmentation2
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.
InjuryAug 10, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DISTAL TIP OF TWO (2) CANNULA DEVICES ((B)(4), LN: 2080429 & (B)(4), LN: 2084981) SHREDDED INSIDE THE PATIENT'S SHOULDER. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED AND IF THERE WAS A SURGICAL DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15203179 ↗InjuryAug 10, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DISTAL TIP OF TWO (2) CANNULA DEVICES ((B)(4), LN: 2080429 & (B)(4), LN: 2084981) SHREDDED INSIDE THE PATIENT'S SHOULDER. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED AND IF THERE WAS A SURGICAL DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATION WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15203069 ↗
Other ACCESSORIES,ARTHROSCOPIC devices
- Arthrex® AR-12990Arthrex, Inc. · Accessories, arthroscopic409 reports
- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page