Arthrex® AR-3355-4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867029842), received between Aug 26, 2019 and Sep 4, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Crack; Crack

  ON 08/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06635147 THAT AN AR-3355-4030 SCOPE HAS A CRACKED LENS AFTER DR. SEDORY WAS ATTEMPTING TO DO A SHOULDER SCOPE AND HIT THE SCOPE WITH A BURR. A NEW SCOPE WAS USED TO COMPLETE THE CASE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20140473 ↗
• MalfunctionAug 21, 2024Crack; Crack

  ON 07/25/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4030 SCOPE WAS HIT WITH A BURR AND THE LENS CRACKED. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20017354 ↗
• MalfunctionJun 10, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON 11/9/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4030 SCOPE HAD A SHARP TIP. THIS WAS DISCOVERED DURING A KNEE SCOPE PROCEDURE, AND PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498297 ↗
• MalfunctionApr 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 03/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4030 SCOPE HAS HOUSING/THREADS THAT HAVE UNRAVELED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061352 ↗
• MalfunctionMar 12, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4)THAT AN AR-3355-4030 SCOPE TOP OF THE HOUSING IS LOOSE (WHERE YOU TWIST IT TO ATTACH TO AND FROM THE CAMERAS). THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888191 ↗
• MalfunctionAug 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 08/03/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN AR-3355-4030 DEVICE CAMERA MOUNT IS COMING APART. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17660885 ↗
• MalfunctionJul 13, 2023Material Opacification; Material Opacification

  ON 6/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3355-4030 SCOPE HAS A CLOUDY LENS. IT WAS INVOLVED IN A CASE. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17314904 ↗
• MalfunctionAug 26, 2019Poor Quality Image

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPIC PROCEDURE, THE IMAGE OF THE ARTHROSCOPE, AR-3355-4030 WAS DULL, DIFFUSED AND BLURRED. THE SURGEON ATTEMPTED TO CLEAN THE LENS BUT THE LENS WAS FOGGY AND STILL DID NOT GIVE A CLEAR IMAGE. NO FURTHER INFORMATION PROVIDED. THE SURGEON HAD TO SWITCH TO ANOTHER TECHNIQUE DURING SURGERY DUE TO THE INCIDENT. SURGEON CHANGED TO A CONVENTIONAL NON-ARTHROSCOPIC TECHNIQUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8932373 ↗