Arthrex® AR-8500RFOERecalls & reported problems
Arthrex, Inc. · BUR,OVAL,FLUSHCUT,RETR,8 FLUT,5.0MMX13C · Class 1
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867259782), received between Aug 18, 2022 and Jan 9, 2025 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (8 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.
Reports received per month
Most reported problems
Device problems
- Break8
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information4
- Foreign Body In Patient1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT DURING A CUFF SURGERY THE TIP BROKE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21114641 ↗MalfunctionJun 7, 2024Break; Break
ON 12/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8500RFOE RETRACTABLE FLUSHCUT BURR HAS BROKEN OFF IN THE PATIENT'S SHOULDER. SURGEON WAS ABLE TO REMOVE THE BROKEN TIP. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 12/16/2022: THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022. PER SALES REPRESENTATIVE, TWO AR-8500RFOE RETRACTABLE FLUSHCUT BURR BROKE CONSECUTIVELY DURING THE PROCEDURE. ALL BROKEN FRAGMENTS FROM BOTH BURR'S WERE RETRIEVED FROM INSIDE THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 19482650 ↗MalfunctionDec 22, 2023Break; Break
IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIP OF THE DEVICE BROKE OFF WHILE MOVING THE TIP FORWARD. THE BROKEN TIP WAS RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18385391 ↗MalfunctionDec 22, 2023Break; Break
IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE TIP OF THE DEVICE BROKE OFF WHILE MOVING THE TIP FORWARD. THE BROKEN TIP WAS RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18385356 ↗MalfunctionApr 28, 2023Break; Break
IT WAS REPORTED, THAT DURING A ROTATOR CUFF SURGERY, THE BURR TIP BROKE OFF. THE BROKEN PART OF THE DEVICE WAS REMOVED FROM THE PATIENT WITH AN INSTRUMENT RETRIEVER. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER SHAVER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE, KHE 19-APR-2023, 2 ORIGINAL PACKED DEVICES WERE RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16837808 ↗MalfunctionJan 3, 2023Break
ON 12/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8500RFOE RETRACTABLE FLUSHCUT BURR HAS BROKEN OFF IN THE PATIENT'S SHOULDER. SURGEON WAS ABLE TO REMOVE THE BROKEN TIP. THIS WAS DISCOVERED DURING A PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16086990 ↗MalfunctionAug 29, 2022Break
IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500RFOE BURR BROKE OFF THE SHAFT. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.
Patient problems: Foreign Body In Patient
MAUDE report 15310783 ↗MalfunctionAug 29, 2022Break
IT WAS REPORTED ON 08/11/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500RFOE BURR BROKE OFF THE SHAFT. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.
Patient problems: Insufficient Information
MAUDE report 15310747 ↗MalfunctionAug 18, 2022Detachment of Device or Device Component
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8500RF0E RETRACTABLE FLUSHCUT BURR HEAD CAME OFF OF THE JOINT AND THE SURGEON HAD TO SEARCH FOR IT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15249368 ↗
Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices
- NA 5820066012Stryker Corporation · Bur, Surgical, General & Plastic Surgery1 recall4 reports
- NA 310.25SSynthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY1 recall0 reports
- Arthrex® AR-8400OBEArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY48 reports
- NA 310.21Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY29 reports
- NA 351.27Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Arthrex® AR-8500OBEArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY27 reports
- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
- Arthrex® AR-8150PX-45Arthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY15 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.