Arthrex® AR-300B-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867202696), received between Nov 30, 2023 and Jun 13, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE DEVICE HAS A WEAK HOLD OF THE BURR AND THE BURR WAS RELEASED DURING THE SURGERY. NO PIECE BROKE OF INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 17-FEB-2021: IT WAS CONFIRMED THAT THE SURGEON NOTICED THE PROBLEM OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531982 ↗
• MalfunctionJun 5, 2024Use of Device Problem; Use of Device Problem

  ON 07/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-300B-2 DRILL ATTACHMENT IS NOT ATTACHING CORRECTLY TO THE AR-300M. THE BURR WAS NOT CUTTING CORRECTLY. THIS OCCURRED DURING AN UNKNOWN CASE, THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469145 ↗
• MalfunctionDec 26, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-300B-2 DRILL ATTACHMENT IS STUCK. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395061 ↗
• MalfunctionNov 30, 2023Difficult to Open or Close; Difficult to Open or Close

  ON 11/06/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-300B-2 DRILL ATTACHMENTS WERE UNABLE TO OPEN UP TO ALLOW THE ATTACHMENT OF A BURR. THIS OCCURRED DURING A CASE CAUSING A DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18241901 ↗
• MalfunctionNov 30, 2023Difficult to Open or Close; Difficult to Open or Close

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT (2) AR-300B-2 DRILL ATTACHMENTS WERE UNABLE TO OPEN UP TO ALLOW THE ATTACHMENT OF A BURR. THIS OCCURRED DURING A CASE CAUSING A DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18241899 ↗