Arthrex® AR-11200FRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867270855), received between Feb 28, 2022 and May 22, 2024 — classified as 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE PLASTIC PLAIN BEARING OF THE SLIDING SHAFT, ON THE JAW SIDE, HAS COME LOOSE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378164 ↗
• MalfunctionMar 14, 2022Output Problem

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT ARTHROSCOPY AN ISSUE WITH THE REPORTED DEVICE OCCURRED. NOTHING BROKE OFF DURING THE SURGERY AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE ANYWAY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 23-FEB-2022 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT A FOREIGN BODY INSIDE A PATIENT WAS IDENTIFIED DURING THE CHECK UP ON AN X-RAY PICTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13757387 ↗
• MalfunctionFeb 28, 2022Device Slipped

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE PIN OF THE JAW FELL OUT OF THE DEVICE. THE SURGEON WAS ABLE TO RETRIEVE THE PIN OUT OF THE PATIENT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620137 ↗
• MalfunctionFeb 28, 2022Device Slipped

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THE PIN OF THE JAW FELL OUT OF THE DEVICE. THE SURGEON WAS ABLE TO RETRIEVE THE PIN OUT OF THE PATIENT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620054 ↗