Arthrex® AR-300-B001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867028630), received between Nov 14, 2024 and Jul 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-06959817 THAT AN AR-300-B001 BURR WAS BENT. THIS OCCURRED DURING A CASE AS THEY WENT TO START AND NOTICED THE BURR WAS SLIGHTLY BENT. THEY WERE ABLE TO REMOVE IT, DISCARD IT, AND REPLACE IT WITH ANOTHER. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT OR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22578092 ↗
• MalfunctionJul 22, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 06/30/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300-B001 BURR STRAIGHT WAS BENT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568401 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT DURING A MINIMALINVASIVE MICA SURGERY THE ATTACHMENT BROKE OFF. THE END REMAINED ATTACHED INSIDE THE ADAPTOR. THE PART BROKE OFF OUTSIDE THE PATIENT. 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. ***UPDATE DW (B)(6) 2024: FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER THAT THE INITIAL REPORTED EVENT WAS INCORRECT. IT WAS CONFIRMED THAT THE ATTACHMENT HAD NO ISSUE BUT AN ARTHREX DRILL BIT HAS BROKEN OFF AND A PART REMAINED STUCK INSIDE THE ATTACHMENT. THE CUSTOMER WAS NOT ABLE TO PROVIDE FURTHER DETAILS WHICH DRILL BIT HAS BROKEN OFF HOWEVER DURING THE EVALUATION A PICTURE OF THE END OF DRILL BIT HAS SHOWN THAT IT HAS A DIAMETER OF 2MM AND THE CUSTOMER ONLY PURCHASED ONE AR-300-B001 WITH THE BATCH 037417 WHICH FITS THIS SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685244 ↗