Arthrex® AR-3355-4070HRecalls & reported problems
Arthrex, Inc. · C-MOUNT HIP AR-SCOPE 70°,3.5X 204MM · Class 2
Data updated Oct 18, 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 00888867029873), received between Jul 20, 2021 and Jul 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2021Break; Entrapment of Device
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPIC / LABRAL RECONSTRUCTION PROCEDURE, THE DISTAL TIP OF THE SCOPE BROKE OFF INTO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION: HALFWAY THROUGH THE CASE THE SURGEON DISCOVERED A PIECE OF THE SCOPE ON THE X-RAY MACHINE INSIDE THE SOFT TISSUE. THE SURGEON MADE SHORT ATTEMPT TO RETRIEVE IT BUT WAS UNSUCCESSFUL AND CONTINUED WITH THE PROCEDURE. AT THE VERY END OF THE CASE THEY SPENT 45 MINUTES TO LOCATE IT INSIDE THE PATIENT AND ADDITIONAL X-RAYS WERE TAKEN BUT THEY WERE UNABLE TO RETRIEVE THE FRAGMENT. THE DOCTOR USED A NON-ARTHREX SHAVER AND BURR WHICH CAME IN CONTACT WITH THE SCOPE WHICH SEVERED PART OF THE SCOPE.
Patient problems: Foreign Body In Patient
MAUDE report 12196505 ↗
Other ARTHROSCOPE devices
- FMS 283512Medos International Sàrl · ARTHROSCOPE1,800 reports
- Arthrex® AR-6480Arthrex, Inc. · ARTHROSCOPE949 reports
- FMS VUE 284002Depuy Mitek, LLC · ARTHROSCOPE829 reports
- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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