Arthrex® AR-8550RBERecalls & reported problems
Arthrex, Inc. · BURR, ROUND, 8 FLUTE 5.5MM X 13CM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867044074), received between Jul 15, 2024 and Jul 15, 2024 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2024Break; Break
ON 06/26/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS- (B)(4) THAT TWO (QTY.2) AR-8550RBE ROUND BURR ATTACHMENTS WERE BROKEN IN THE HUB AT THE ATTACHMENT CONNECTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740052 ↗MalfunctionJul 15, 2024Break; Break
ON 06/26/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS (B)(4) THAT TWO (QTY.2) AR-8550RBE ROUND BURR ATTACHMENTS WERE BROKEN IN THE HUB AT THE ATTACHMENT CONNECTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740051 ↗
Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices
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- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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