Arthrex® AR-3355-4050Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867405851), received between May 14, 2024 and Sep 28, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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.

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 28, 2026Break

  On 10-Sep-2026, a Sales Representative reported via (b)(6)that an AR-3355-4050 Arthroscope broke when a reamer was taken to it. This occurred during a case, with no harm to the patient.On 17-Sept-2026 additional information was received via email from the Sales Representative who provided the following additional information: The event occurred on (b)(6)2026. The procedure was a Shoulder Arthroscopy. The device broke when the Doctor hit the scope with a reamer. No videos or images were captured of the event. All fragments were retrieved from the patient. A new scope was used to complete the procedure. The only delay was when switching to a new scope. No additional anesthesia was administered.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914518 ↗
• MalfunctionNov 24, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A SURGERY THE PATIENT EXPERIENCED AN INVOLUNTARY ARM MOVEMENT WHICH CAUSED THE "FISH EYE" END OF THE PANOSCOPE TO COME INTO CONTACT WITH THE SHEATH. THIS RESULTED IN DAMAGE TO BOTH THE SCOPE AND THE SHEATH. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631303 ↗
• MalfunctionNov 5, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON 10/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06691629 THAT AN AR-3355-4050 SCOPE'S TIP WAS HIT WITH A SHAVER. HAPPENED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610295 ↗
• MalfunctionAug 26, 2024Defective Device; Defective Device

  ON 08/02/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-3355-4050 PANO ARTHROSCOPES HAD AN EDGE TO IT LIKE IT GOT SHAVED DAMAGED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066469 ↗
• MalfunctionAug 26, 2024Defective Device; Defective Device

  ON 08/02/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-3355-4050 PANO ARTHROSCOPES HAD AN EDGE TO IT LIKE IT GOT SHAVED DAMAGED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066457 ↗
• MalfunctionJul 3, 2024Defective Device; Defective Device

  ON 06/05/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3355-4050 SCOPE STOPPED WORKING DURING A CASE. DISCOVERED DURING CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665420 ↗
• MalfunctionJun 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 05/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06566603 THAT AN AR-3355-4050 SCOPE HAS A DISTAL LENS THAT IS DISENGAGED AND ROLLING INTO THE TIP OF THE SCOPE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492038 ↗
• MalfunctionMay 14, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON 04/18/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06543064 THAT AN AR-3355-4050 SCOPE GOT NICKED BY A SHAVER AND WAS DAMAGED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19316037 ↗