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STERLING H9101Recalls & reported problems

Conmed Corporation · STERLING OVAL BUR, 4.0 MM · Class 1

Data updated Oct 18, 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 10845854017210), received between Dec 18, 2018 and Feb 26, 2019 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Break1
  • Material Fragmentation1

Patient problems

  • No Consequences Or Impact To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 26, 2019Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED THE H9101, SHAVER BUR, FELL OFF IN A SHOULDER JOINT DURING AND ARTHROSCOPIC SHOULDER PROCEDURE ON (B)(6) 2019. THE BUR FRAGMENT WAS SAFELY REMOVED FROM THE PATIENT'S JOINT. THERE WERE NO ISSUES NOTICED WITH THE BUR PRIOR TO USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME TYPE OF BUR AND LOT NUMBER. THERE WERE NO REPORTED PATIENT OR USER INJURIES AND NO REPORTED DELAY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8370741 ↗
  • MalfunctionDec 18, 2018Break; Break

    THE CUSTOMER REPORTED THE H9101 BUR, BROKE OFF IN THE PATIENT'S BONE DURING A SHOULDER ARTHROSCOPY PROCEDURE. THE BUR WAS BEING USED THROUGH A CANNULA TO RESECT BONE WHEN IT BROKE OFF. THE FRAGMENT WAS RETRIEVED USING A KELLY CLAMP AND GRASPER. THERE WAS NO PATIENT INJURY. THERE WAS NO REPORTED DELAY AND THE PROCEDURE WAS COMPLETED AS PLANNED. NO OTHER BUR WAS NEEDED TO FINISH THE SURGERY. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8176148 ↗

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Sources and updates

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