Arthrex® AR-7300OBTRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867041950), received between Jul 11, 2022 and Mar 17, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionMar 17, 2025Break; Break

  ON 02/28/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-7300BT BURR 3.0 BONE BLADE BROKE. THIS OCCURRED DURING USE AND THEY HAD TO OPEN ANOTHER ONE TO FINISH THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21619478 ↗
• MalfunctionNov 21, 2024Break; Break

  ON 11/08/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-7300OBT OVAL BURR SHAVER BLADE BENT AND BROKE DURING THE PROCEDURE. THE BLADE BENT WHEN IT WAS IN THE MEDIAL PORTION OF THE TRAPEZIUS. THE TECHNIQUE WAS CARRIED OUT CORRECTLY. NO FRAGMENTS REMAINED INSIDE THE PATIENT. THIS OCCURRED DURING USE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750811 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY OF THE ANKLE THE DEVICE BROKE. THE DEVICE BROKE INSIDE THE PATIENT BUT ALL PARTS WERE RETRIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 19589812 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY OF THE ANKLE THE DEVICE BROKE. THE DEVICE BROKE INSIDE THE PATIENT BUT ALL PARTS WERE RETRIEVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 19562861 ↗
• MalfunctionJul 11, 2022Break

  ON (B)(6) 2022 IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-7300OBT OVAL BURR BROKE 1CM FROM THE TOP, THE BROKE FRAGMENT WAS RETRIEVED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED. ON (B)(6) 2022 IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-7300OBT OVAL BURR BROKE 1CM FROM THE TOP INSIDE THE PATIENT¿S ANKLE DURING USE, THE BROKE FRAGMENT WAS RETRIEVED. THIS WAS DISCOVERED DURING USE IN AN ANKLE PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976417 ↗