Arthrex® AR-11900SRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867003828), received between Dec 7, 2021 and Jun 27, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2022Break

  IT WAS REPORTED THAT THE UPPER PART OF THE GRASP BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. (B)(6) 2022 UPDATE DW. FURTHER INFORMATION WERE PROVIDED THAT THE PART BROKE OFF DURING A SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14829328 ↗
• MalfunctionDec 7, 2021Break

  IT WAS REPORTED THAT THE TIP IS BROKEN OFF. 18-NOV-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE REPORTED EVENT OCCURRED SOME TIME AGO DURING A SURGERY. THE CUSTOMER DOES NOT REMEMBER WHEN AND HOW THE TIP OF THE REPORTED DEVICE BROKE OFF. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12953290 ↗