Arthrex® AR-8500TBTRecalls & reported problems
Arthrex, Inc. · BURR, TAPERED, 12 FLUTE 5.0MM X 13CM · Class 1
Data updated Oct 18, 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 00888867043916), received between Jan 9, 2024 and Jan 9, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Device” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2024Defective Device; Defective Device
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-8500TBT TAPERED BURR IS MISALIGNED AND IS VIBRATING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18477105 ↗MalfunctionJan 9, 2024Defective Device; Defective Device
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-8500TBT TAPERED BURR IS MISALIGNED AND IS VIBRATING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475607 ↗MalfunctionJan 9, 2024Defective Device; Defective Device
ON 12/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06432750 THAT AN AR-8500TBT TAPERED BURR IS MISALIGNED AND IS VIBRATING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18475595 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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