Arthrex® AR-300BRecalls & reported problems
Arthrex, Inc. · BURR ATTACHMENT 2.35 MM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is an Arthrex AR-300B burr attachment, an orthopedic surgical tool. Many of the 83 reports describe attachments breaking, locking mechanisms failing, sticking, and rattling or overheating during use. There are 4 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 87
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00888867099968), received between Nov 26, 2019 and Sep 15, 2026 — classified as 4 injuries, 83 malfunctions.
The most frequently reported specific device problem is “Break” (28 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
- Break28
- Defective Device8
- Physical Resistance/Sticking7
- Positioning Failure6
- Use of Device Problem5
- Fitting Problem4
- Overheating of Device4
- Unintended Movement4
Patient problems
- No Clinical Signs, Symptoms or Conditions74
- Insufficient Information10
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Burn(s)1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Vibration
It was reported by an agency representative from Cetas Healthcare as part of the PMCF survey on Arthrex Power Systems (CER-F) that, during an arthroscopic shoulder debridement procedure, excessive vibration and/or abnormal noise was observed during operation of the Burr Attachment 2.35 mm (AR-300B). The healthcare professional reported that the same or a similar event had not been experienced previously. No patient injury, user injury, or adverse health consequences were reported, and no additional treatment or intervention was required as a result of the event. The complaint was considered possibly related to the device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774742 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719068 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718410 ↗MalfunctionAug 4, 2026Mechanical Problem; Defective Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50127273 ↗MalfunctionJul 7, 2026Break
ON 11-JUNE-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-200M SHAVE HAD A BROKEN BURR INSIDE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25738096 ↗MalfunctionApr 17, 2026Positioning Failure
ON 27-MAR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE LOCKING MECHANISM ON THE AR-300B BURR ATTACHMENT IS NOT WORKING. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24909944 ↗MalfunctionMar 9, 2026Overheating of Device; Noise, Audible
ON 16-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT WAS MAKING A LOUD RATTLING SOUND AND GETTING REALLY HOT AS THE BURR WAS RUN. THIS WAS DISCOVERED AFTER USE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24544173 ↗MalfunctionFeb 23, 2026Break
ON 26-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT'S LOCKING MECHANISM IS BROKEN. ISSUE DISCOVERED DURING THE CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413588 ↗MalfunctionFeb 13, 2026Break
ON 26-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 4 OF AR-300B BURR ATTACHMENTS WERE BROKEN. NO FURTHER DETAILS WERE PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 29-JAN-2026: IT WAS FURTHER REPORTED THAT THE ISSUE WITH THE BURR WAS THAT IT NO LONGER FUNCTIONED PROPERLY AND IMPACTED OTHER PARTS OF THE SYSTEM. THE ISSUE WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION PROVIDED 05-FEB-2026: IT WAS REPORTED THAT THE AR-300B BURRS WERE BREAKING OFF INSIDE THE HANDPIECES AND THE TIPS WERE OVERHEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24331488 ↗MalfunctionFeb 12, 2026Break
ON 26-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 4 OF AR-300B BURR ATTACHMENTS WERE BROKEN. NO FURTHER DETAILS WERE PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 29-JAN-2026: IT WAS FURTHER REPORTED THAT THE ISSUE WITH THE BURR WAS THAT IT NO LONGER FUNCTIONED PROPERLY AND IMPACTED OTHER PARTS OF THE SYSTEM. THE ISSUE WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION PROVIDED 05-FEB-2026: IT WAS REPORTED THAT THE AR-300B BURRS WERE BREAKING OFF INSIDE THE HANDPIECES AND THE TIPS WERE OVERHEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326543 ↗MalfunctionFeb 12, 2026Break
ON 26-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 4 OF AR-300B BURR ATTACHMENTS WERE BROKEN. NO FURTHER DETAILS WERE PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 29-JAN-2026: IT WAS FURTHER REPORTED THAT THE ISSUE WITH THE BURR WAS THAT IT NO LONGER FUNCTIONED PROPERLY AND IMPACTED OTHER PARTS OF THE SYSTEM. THE ISSUE WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION PROVIDED 05-FEB-2026: IT WAS REPORTED THAT THE AR-300B BURRS WERE BREAKING OFF INSIDE THE HANDPIECES AND THE TIPS WERE OVERHEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326423 ↗MalfunctionFeb 12, 2026Break
ON 26-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 4 OF AR-300B BURR ATTACHMENTS WERE BROKEN. NO FURTHER DETAILS WERE PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 29-JAN-2026: IT WAS FURTHER REPORTED THAT THE ISSUE WITH THE BURR WAS THAT IT NO LONGER FUNCTIONED PROPERLY AND IMPACTED OTHER PARTS OF THE SYSTEM. THE ISSUE WAS DISCOVERED DURING USE WITH NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION PROVIDED 05-FEB-2026: IT WAS REPORTED THAT THE AR-300B BURRS WERE BREAKING OFF INSIDE THE HANDPIECES, AND THE TIPS WERE OVERHEATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24326100 ↗MalfunctionFeb 11, 2026Positioning Failure
ON 22-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR WOULD NOT FIT INTO THE INSTRUMENT. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313418 ↗MalfunctionJan 14, 2026Overheating of Device
ON 17-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT GETS HOT DURING USE. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067048 ↗MalfunctionJan 12, 2026Defective Device
ON 22-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT IS DAMAGED. FOUND DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24036256 ↗MalfunctionJan 8, 2026Use of Device Problem
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-07159800 THAT AN AR-300B BURR ADAPTER IS HAVING DIFFICULTY ACCEPTING BURRS. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001837 ↗MalfunctionNov 25, 2025Break; Break
ON 10/31/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT HAD A BURR BREAK OFF INSIDE. NOTICED DURING A CASE, DEVICE WAS REPLACED AND CASE COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23649631 ↗MalfunctionNov 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 10/21/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT A BURR BROKE OFF INTO AN AR-300B ATTACHMENT, AND THE STEM WAS STUCK INSIDE, PREVENTING ANOTHER ATTACHMENT FROM CONNECTING. DEVICE SWAPPED AND CASE COMPLETED WITH NO PATIENT EFFECT. ADDITIONAL INFO PROVIDED 10/31: AR-300-B102 BURR WAS BROKEN DURING PROCEDURE, NO ADVERSE EFFECTS OR FRAGMENTS PRODUCED FROM BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496122 ↗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 23452090 ↗MalfunctionSep 18, 2025Break; Break
ON 08/29/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT 2.35 MM HAS BROKEN OFF INSIDE THE DEVICE, AND IT WILL NOT COME OUT. THE ISSUE WAS DISCOVERED DURING THE SURGERY. ANOTHER DEVICE WAS SWAPPED, AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23089513 ↗MalfunctionAug 11, 2025Break; Break
ON 07/24/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT IS BROKEN. NO FURTHER INFORMATION WAS PROVIDED. NO INFORMATION ON A CASE OR PATIENT WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22773117 ↗MalfunctionJul 31, 2025Use of Device Problem; Defective Device; Use of Device Problem; Defective Device
ON 07/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT BURRS WERE NOT ABLE TO GET DOWN TO THE TEETH. IF THE BURRS GET DOWN AT ALL, IT DID NOT RELEASE THE BURR. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22676591 ↗MalfunctionJul 8, 2025Difficult to Insert; Difficult to Insert
ON 06/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR IS NOT MATING WITH THE HANDPIECE. NOTICED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22437198 ↗MalfunctionJun 23, 2025Positioning Failure; Positioning Failure
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-300B BURR'S LOCKING MECHANISM IS NOT HOLDING. DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22309689 ↗MalfunctionMay 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 04/30/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-300B BURR ATTACHMENT WAS STUCK IN THE TIP AND WON¿T COME OUT. THIS HAPPENED DURING A CASE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22051135 ↗
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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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