STERLING H9103RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854018590), received between Jan 22, 2019 and Jun 23, 2025 — 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 23, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE H9103RH, STERLING OVAL BUR, 5.0 MM DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND ¿BURS ALL SNAPPED AT THE CONNECTION POINT TO THE HANDPIECE. ALL 3 BURS SNAPPED AND BROKE INTRA OPERATIVE UNDER MINIMUM FORCE, ALL PIECES WERE RECOVERED FROM PATIENT AND NO PATIENT NEGATIVE OUTCOME HAPPENED.¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306588 ↗
• MalfunctionJan 22, 2019Break; Break

  THE CUSTOMER REPORTED THE H9103RH, SHAVER BUR "BROKE AT HUB DURING SURGERY ON (B)(6) 2018, ALL PARTS REMOVED. NO INJURY" PHOTOS WERE PROVIDED TO SHOW THE BROKEN BUR. ADDITIONAL INFORMATION RECEIVED STATED THERE WAS NO DELAY OF SURGERY, NO ISSUES WITH INSERTING THE BUR INTO THE SHAVER HANDPIECE AND ANOTHER OF THE SAME BUR WAS USED TO COMPLETE THE SURGERY. THE BUR BROKE IN THE MIDDLE OF SURGERY AND IT WAS BEING USED THROUGH THE CANNULA, NOT THE INCISION SITE. THERE WERE NO OTHER INSTRUMENTS IN USE WITH THE BUR AND THE STAFF WAS FAMILIAR WITH USING THE PRODUCT. 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 8266833 ↗