Arthrex® AR-3355-4031Recalls & reported problems
Arthrex, Inc. · 4K C-Mount Arthroscope, 30°,4mm x152.5mm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888867291751), received between Aug 8, 2022 and Apr 25, 2025 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Break” (5 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
- Break5
- Defective Device3
- Crack2
- Sharp Edges2
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
- Fitting Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2025Sharp Edges; Sharp Edges
ON (B)(6) 2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4031 ARTHROSCOPE LENS HAD A SHARP EDGE. THIS WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908950 ↗MalfunctionSep 10, 2024Defective Device; Defective Device
ON 08/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-3355-4031 SCOPE HAS SHARP METAL EDGES AROUND THE TIP. DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20181486 ↗MalfunctionSep 3, 2024Crack; Crack
ON (B)(6) 2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4031 ARTHROSCOPE WAS HIT WITH A BURR AND THE LENS CRACKED. THIS WAS DISCOVERED DURING THE CASE. ANOTHER SCOPE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20123982 ↗MalfunctionAug 23, 2024Break; Break
ON 07/31/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-3355-4031 ARTHROSCOPE METAL WAS BROKEN AT THE HUB NOT ALLOWING IT TO SCREW INTO THE CAMERA HEAD. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20054614 ↗MalfunctionAug 22, 2024Crack; Crack
ON 08/02/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-3355-4031 SCOPE WAS HIT WITH A BURR DURING A PROCEDURE AND VISIBLY CRACKED. ANOTHER SCOPE WAS BROUGHT IN, AND CASE COMPLETED. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20042866 ↗MalfunctionJun 21, 2024Fitting Problem; Fitting Problem
ON 05/24/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4031 SCOPE IS NOT REMAINING SCREWED ON TO THE C-MOUNT PORTION OF THE CAMERA. CASE/PATIENT INVOLVEMENT NOT INDICATED.
Patient problems: Insufficient Information
MAUDE report 19580329 ↗MalfunctionJun 6, 2024Break; Break
ON 03/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4031 SCOPE FELL APART WHERE THE BACK SCREWS INTO THE CAMERA. PATIENT NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19480684 ↗MalfunctionJun 5, 2024Material Separation; Material Separation
IT WAS REPORTED ON 03/09/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3355-4031 C-MOUNT IS COMING APART EASILY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472878 ↗MalfunctionApr 26, 2024Break; Break
ON 04/02/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06529665 THAT AN AR-3355-4031 SCOPE'S WHOLE BACK PIECE FELL APART. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19193847 ↗MalfunctionFeb 27, 2024Sharp Edges; Sharp Edges
ON 02/8/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4031 HAD SHARP EDGES. THIS WAS DISCOVERED DURING A CASE. THE SCOPE WAS REPLACED WHEN THIS PROBLEM WAS DISCOVERED. THERE WAS CASE INVOLVEMENT. HOWEVER, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18790262 ↗MalfunctionNov 27, 2023Device Damaged by Another Device; Device Damaged by Another Device
ON 11/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4031 ARTHROSCOPE WAS HIT WITH A BURR. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18209585 ↗MalfunctionNov 16, 2023Defective Device; Defective Device
ON 10/30/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4031 4K C-MOUNT ARTHROSCOPE WAS NOT ROTATING PROPERLY AND (QTY. 2) OF AN AR-8330H SHAVER HP WOULD NOT ROTATE PROPERLY THE ATTACHMENT. THIS WAS DISCOVERED DURING AN ARTHROSCOPY PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150419 ↗MalfunctionSep 15, 2023Defective Device; Defective Device
ON (B)(6)/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4031 4K C-MOUNT ARTHROSCOPE WOULD NOT SWIVEL INDEPENDENTLY FOR THE RESOLUTION TO BE SEEN/ADJUSTED ON THE SCOPE. THIS WAS DISCOVERED DURING USE. THE CASE WAS COMPLETED WITH A DIFFERENT SCOPE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17758319 ↗MalfunctionMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4031 SCOPE WAS COMPLETELY DISMANTLED. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE. ALL FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW SCOPE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16544530 ↗MalfunctionDec 6, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4031 SCOPE TIP BROKE-OFF OF THE SCOPE HEAD. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15923335 ↗MalfunctionAug 8, 2022Break; Output Problem
IT WAS REPORTED THAT THE SCOPE FELL APART DURING FIRST USE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. UPDATE 20-JUL-2022: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING AN ARTHROSCOPY SURGERY AND A PART OF THE DEVICE BROKE OFF. THE PICTURE SHOWS THAT THE THREADED PART OF THE DEVICE REMAINED ON THE CAMERA HEAD. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15183302 ↗
Other Arthroscope devices
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- 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 13, 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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