STERLING H9112RHRecalls & reported problems
Conmed Corporation · STERLING, SPHERICAL BUR, REDUCED HOOD, 5.5 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 10845854029640), received between Jul 3, 2018 and Jul 3, 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2018Break; Break
THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A SHOULDER CASE, THE TIP OF THE H9112RH BUR BROKE OFF AND FELL INTO THE PATIENT. THE TIP WAS RETRIEVED WITH A GRASPER. THERE WAS A 5 MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. UPON GATHERING ADDITIONAL INFORMATION, IT WAS REPORTED THE PROCEDURE AND PATIENT'S RECOVERY WAS AS EXPECTED. THIS REPORT IS BEING RAISED ON THE BASIS OF A REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7659620 ↗
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- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
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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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