CONMED 00509123600Recalls & reported problems
Conmed Corporation · OVAL BUR, MEDIUM, 4 X 8 MM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854007488), received between Jan 19, 2018 and Jan 19, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2018Break; Break
A CUSTOMER REPORTED DURING A SHOULDER SURGERY, THE HEAD OF A 00509123600 OVAL BUR BROKE. FOLLOW-UP CONFIRMED THE BREAKAGE OCCURRED WHILE THE BUR WAS TESTED BY THE NURSE BEFORE START OF SURGERY. THE BUR DID NOT BREAK IN THE PATIENT AND ALL BROKEN PIECES WERE ACCOUNTED FOR. AN ALTERNATIVE BUR WAS USED IN A MICROPOWER PLUS DRILL ON THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A TEN MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. THIS REPORTED IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.
Patient problems: No Patient Involvement
MAUDE report 7207353 ↗
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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