Arthrex® AR-300-B202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867185821), received between Dec 7, 2023 and Nov 3, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 10/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING AN MIS: EXCISION, EXOSTOSIS-LEFT PLANTAR MIDFOOT EXOSTECTOMY A METAL "SNAPPING" SOUND WAS HEARD. UPON INSPECTION, IT WAS FOUND THAT THE NON-CUTTING SIDE OF THE AR-300-B202 BURR THAT SITS WITHIN THE AR-300B BURR ATTACHMENT HAD SHEARED OFF, LEAVING A FRAGMENT OF THE BURR LODGED INSIDE THE ATTACHMENT. THIS WAS DISCOVERED TOWARD THE END OF THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452264 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A FLATFOOT RECONSTRUCTION SURGERY THE DEVICE BROKE INSIDE THE HANDPIECE. PER COMPLAINT REPORTER 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 21755033 ↗
• MalfunctionMar 20, 2024Overheating of Device; Overheating of Device

  ON 03/05/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300-B202 BURR WAS CAUSING THE SHAVER TO OVERHEAT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. "ONCE THE INCISION WAS MADE THE SURGEON STARTED TO USE THE BURR ON THE CALCANEUS. WITHIN MINUTES THE HAND PIECE WAS STARTING TO GET WARM. IRRIGATION WAS FLOWING AS NORMAL. WE THEN SWITCHED OUT THE BURR FOR A DIFFERENT ONE AND THE HAND PIECE COOLED OFF AND WORKED AS IT SHOULD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942717 ↗
• MalfunctionJan 3, 2024Material Fragmentation; Material Fragmentation

  ON 12/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-300B BURR ATTACHMENT AND AN AR-300-B202 BURR HAD AN ISSUE. DURING A ROUTINE MINIMALLY INVASIVE SURGERY (MIS) CALCANEAL SLIDE, AR-300-B202 BROKE OFF AT THE SHAFT DURING JOINT PREP. THE SURGEON WAS ABLE TO REMOVE THE BURR HEAD FROM THE BONE, BUT THE INSERTER PORTION OF THE BURR IS IN AR-300B (HEAD PORTION OF MIS HANDPIECE) AND UNABLE TO BE REMOVED BY MULTIPLE PEOPLE. THE CASE WAS COMPLETED BY OPENING A NEW HANDPIECE AND BURR TO COMPLETE THE PROCEDURE WITH NO PIECES LEFT IN THE PATIENT. THERE WAS A 5 MINUTE DELAY DUE TO REMOVING THE BURR AND OPENING A NEW HANDPIECE/BURR. IT WAS STATED THAT THE SURGEON DOES AROUND 8 MIS CALC SLIDES MONTHLY AND IS VERY COMFORTABLE WITH THE PROCEDURE. THIS WAS DISCOVERED DURING A CALC OSTEOTOMY PROCEDURE ON (B)(6) 2023, WITH NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438413 ↗
• InjuryDec 7, 2023Defective Device; Defective Device

  ON 11/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-200M MOTOR WITH CABLE 3.5M WAS NOT RECOGNIZED ON THE CONSOLE AND THE CUSTOMER HAD TO BE OPENED UP INSTEAD OF DOING MINIMALLY INVASIVE SURGERY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 11/14/2023: THIS WAS DISCOVERED DURING A MIS BUNION PROCEDURE. INSTEAD OF DOING MINIMALLY INVASIVE SURGERY, THE INCISION WAS REQUIRED TO BE OPENED, AND THE BONE WAS EXCISED WITH A RONGEUR AND A SAW. THE PATIENT'S QUALITY OF LIFE WAS NOT REDUCED; HEALING TIME AND OUTCOME OF THE SURGERY MAY HAVE BEEN AFFECTED. THE CASE WAS COMPLETED BY OPENING THE INCISION AND REVERTING TO AN OPEN PROCEDURE. THERE WAS A REPORTED 30-45 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL ANESTHESIA ADMINISTERED. THE PATIENT'S HEALTH STATUS WAS STATED AS "OKAY."

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282774 ↗