Arthrex® AR-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867184169), received between Nov 9, 2022 and Sep 10, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Device Damaged by Another Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717879 ↗
• MalfunctionMar 23, 2026Overheating of Device

  ON 3-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07255111 THAT AN AR-200 OF AR-200M MOTOR CABLE WAS GETTING HOT TO THE TOUCH AND SMOKING. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24668347 ↗
• MalfunctionAug 7, 2025Temperature Problem; Temperature Problem

  ON 07/18/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-200M MOTOR OF AR-200 IS WARM TO THE TOUCH WHEN RUNNING. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738097 ↗
• MalfunctionJun 13, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A MIS FOREFOOT SURGERY THE DEVICE DID NOT WORK. THE DISPLAY SHOWED WITH BOTH AND DEVICES AND HAND PIECES THE ERROR MESSAGE "HAND PIECE NOT CONNECTED". THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533281 ↗
• InjuryJul 10, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SURGERY WHEN ATTACHING TO THE DEVICE TWO DIFFERENT ERRORS APPEARED. ONE THAT STATED THAT THE UNIT IS NOT RECOGNISED AND ANOTHER THAT THERE IS AN ERROR OF THE UNIT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 19-JUN-2023: IT WAS FURTHER REPORTED THAT THE FAILURE WAS NOTICED BEFORE THE SURGERY WHEN CONNECTING THE DEVICES SHORTLY BEFORE THE SURGERY. A MINIMALLY INVASIVE SURGERY WAS PLANNED WITH THE REPORTED DEVICE. DUE TO THE FAILURE THE SURGEON HAD TO SWITCH THE HALLUX RIGIDUS PROCEDURE BY OPENING THE JOINT TO AN OPEN SURGERY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH DIFFERENT DEVICES (STRYKER SAW AND DRILL). IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE AVOE 19-JUN-2023: IT WAS CONFIRMED THAT THE PATIENT WAS ALREADY ANESTHETIZED WHEN THE ERROR WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286640 ↗
• MalfunctionNov 9, 2022Display or Visual Feedback Problem; Manufacturing, Packaging or Shipping Problem

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-200 INSTRUMENT IS NOT RECOGNIZED WHEN PLUGGED IN, WHICH DISPLAYED A CONSOLE ERROR SAYING "HANDPIECE NOT ATTACHED (?)". THIS WAS DISCOVERED OUT-OF-BOX DURING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY AN OPEN TECHNIQUE AS MINIMALLY INVASIVE SURGERY WAS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758613 ↗