Arthrex® AR-8550RFOERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867259799), received between Dec 5, 2022 and Jun 17, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2024Break; Break

  ON 5/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8550RFOE RETRACTABLE FLUSHCUT BURR HAD THE HEAD OF THE BURR BREAK OFF INTO THE JOINT DURING USE. THEY HAD TO USE A GRASPER TO RETRIEVE THE BROKEN PART OF THE BURR, AND A NEW AR-8550RFOE RETRACTABLE FLUSHCUT BURR WAS OPENED TO FINISH THE CASE. THERE WAS A 5-MINUTE DELAY IN THE CASE TO RETRIEVE THE BROKEN PIECE. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 5/28/2024: THERE WAS NOT AN INTERRUPTION OF FLOW, BUT THE DEVICE BROKE IN THE JOINT AND A GRASPER WAS USED TO GET THIS PIECE OUT OF THE SHOULDER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AND WERE ABLE TO RETRIEVE THE BROKEN PIECE OUT OF THE PATIENT. THE ADDED 5 MINUTES TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549158 ↗
• MalfunctionMar 19, 2024Break; Break

  ON 3/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8550RFOE RETRACTABLE FLUSHCUT BURR HEAD BROKE OFF THE SHAFT OF THE BURR AND WAS LODGED INTO THE JOINT AFTER THE SURGEON TOOK THE HANDPIECE OUT. A GRASPER WAS ABLE TO RETRIEVE THE HEAD OF THE BURR. THE CASE WAS COMPLETED USING A NEW BURR. THIS WAS DISCOVERED DURING A SHOULDER PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 3/12/2024: THIS WAS DISCOVERED DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR, DISTAL CLAVICLE, AND BICEPS TENODESIS PROCEDURE ON (B)(6) 2024. THERE WAS A SLIGHT DELAY WITH THE DEFECTIVE 5.5 BURR. THE BURR HEAD CAME ENTIRELY OFF THE INNER SLEEVE OF THE BURR. THEY HAD A SECOND BURR IN THE ROOM AND WERE ABLE TO SWITCH IT OUT QUICKLY. ONLY INFLOW WAS BEING USED, AND FLOW THROUGH THE DEFECTIVE DEVICE WAS NOT INTERRUPTED. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS AS THEY WERE ABLE TO RETRIEVE ALL PARTS OF THE BURR THAT CAME APART IN THE JOINT WITH A GRASPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935499 ↗
• MalfunctionMar 8, 2024Break; Break

  ON 2/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE ADHESIVE FROM AN AR-8550RFOE RETRACTABLE FLUSHCUT BURR THAT KEEPS THE BURR ATTACHED BROKE OFF. THE BURR BLADE WAS FLOATING IN THE PATIENT'S ACROMIOCLAVICULAR JOINT. THE SURGEON REMOVED THE FRAGMENTS SUCCESSFULLY AND COMPLETED THE CASE USING A NEW BLADE. THIS WAS DISCOVERED DURING A PROCEDURE. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869224 ↗
• MalfunctionDec 4, 2023Break; Break

  ON 11/08/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-8550RFOE RETRACTABLE FLUSHCUT¿ BURR BROKE. THIS OCCURRED DURING A CASE WHERE THE BURRS WERE SWITCHED OUT TO COMPLETE THE CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18259490 ↗
• MalfunctionDec 4, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-8550RFOE RETRACTABLE FLUSHCUT¿ BURR BROKE. THIS OCCURRED DURING A CASE WHERE THE BURRS WERE SWITCHED OUT TO COMPLETE THE CASE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18259063 ↗
• MalfunctionMar 2, 2023Break

  IT WAS REPORTED ON (B)(6) 2023 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8550RFOE BURR BROKE OFF INSIDE PATIENT. CASE INVOLVEMENT, DEVICE BROKE DURING USE. PER FACILITY: "RETRACTABLE BURR BROKE OFF INSIDE PATIENT LESS THAN 30 SECONDS INTO USING. DID NOT START THE BURR ON BONE."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466189 ↗
• MalfunctionDec 5, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8550RFOE RETRACTABLE FLUSHCUT BURR TIP BROKE OFF FROM THE SHAFT. SURGEON WAS ABLE TO RETRIEVE THE PIECE FROM THE PATIENT'S SHOULDER AND COMPLETE CASE WITH ANOTHER BURR. THIS WAS DISCOVERED DURING A SHOULDER SCOPE DISTAL CLAVICLE EXCISION PROCEDURE ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914212 ↗