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STERLING H9101RHRecalls & reported problems

Conmed Corporation · STERLING OVAL BUR, REDUCED HOOD, 4.0 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 10845854029626), received between Dec 8, 2017 and Dec 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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

  • Material Fragmentation1

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.

  • MalfunctionDec 8, 2017Material Fragmentation; Material Fragmentation

    THE CONMED SALES REPRESENTATIVE REPORTED ON BEHALF OF THE USER FACILITY THAT DURING A SUBACROMIAL DECOMPRESSION PROCEDURE, THE H9101RH STERLING OVAL BUR SPLIT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED SURGICAL DELAYS. NO PATIENT INJURY REPORTED. UPON GATHERING ADDITIONAL INFORMATION, IT IS UNKNOWN IF ALL METAL FRAGMENTS WERE RETRIEVED SINCE THEY WERE SO SMALL. THE PATIENT DID NOT REQUIRE ADDITIONAL TREATMENT DUE TO THIS EVENT. THIS REPORT IS 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 7102062 ↗

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Sources and updates

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