Arthrex® AR-6500RRBERecalls & reported problems
Arthrex, Inc. · BURR,ROUND,HL,RETRACT,8 FLUTE,5.0MMX18CM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867258747), received between Feb 28, 2022 and Nov 1, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPIC LABRAL REPAIR SURGERY, THE PLASTIC SLEEVE INSIDE THE BURR CAME APART CAUSING THE BURR TO GET STUCK. THIS HAPPENED AFTER 5 MINUTES OF USING THE BURR. ACCORDING TO THE SURGEON, NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 18046349 ↗MalfunctionFeb 28, 2022Break
ON (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-6500RRBE BURR MECHANISM BREAKS AND STOPS SPINNING. SURGEON THOUGHT IT MIGHT BE CLOGGED BUT EVEN AFTER CLEANING THE BURR, ISSUE PERSISTED. THIS WAS DISCOVERED DURING A PROCEDURE. WHEN SURGEON TRIED USING A DIFFERENT BURR, IT BROKE AS SOON AS IT HIT BONE. THIS OCCURRED AGAIN WITH A THIRD BURR FROM A DIFFERENT LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13621819 ↗MalfunctionFeb 28, 2022Break; Output Problem
ON (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-6500RRBE BURR MECHANISM BREAKS AND STOPS SPINNING. SURGEON THOUGHT IT MIGHT BE CLOGGED BUT EVEN AFTER CLEANING THE BURR, ISSUE PERSISTED. THIS WAS DISCOVERED DURING A PROCEDURE. WHEN SURGEON TRIED USING A DIFFERENT BURR, IT BROKE AS SOON AS IT HIT BONE. THIS OCCURRED AGAIN WITH A THIRD BURR FROM A DIFFERENT LOT NUMBER.
Patient problems: Insufficient Information
MAUDE report 13621256 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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