STERLING H9110Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10845854012802), received between Jul 3, 2018 and Apr 1, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 reports).

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE H9110, STERLING SPHERICAL BUR, 3.5 MM DEVICE WAS USED IN A ROBOT-ASSISTED INFERIOR RECTAL RESECTION PROCEDURE ON (B)(6) 2026, AND ¿THE INNER CORE OF THIS CONSUMABLE BROKE AND IT IS NO LONGER USABLE¿. FURTHER ASSESSMENT FOUND THE DEVICE FRAGMENTED, A FRAGMENT FELL INTO THE SURGICAL SITE AND WAS REMOVED WITH MEDICAL FORCEPS. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 24753053 ↗
• MalfunctionMar 30, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE H9110 STERLING SPHERICAL BUR, 3.5 MM DEVICE, WAS BEING USED DURING AN ARTHROSCOPIC ANKLE JOINT FIXATION PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, "AN ABRADER BAR WAS BROKEN DURING THE SURGERY.". FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT OR FALL INTO THE SURGICAL SITE AND WAS REMOVED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711940 ↗
• MalfunctionDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, H9110, STERLING SPHERICAL BUR, 3.5 MM, WAS BEING USED ON (B)(6) 2024 AND ¿THE DOCTOR USES THE SHAVER BURR UNTIL SHAVINGS BEGIN TO COME OUT, THE DOCTOR REMOVES THE INPUT AND REALIZES THAT A PIECE IS MISSING THAT WAS LEFT INSIDE THE PATIENT AND THAT HE WAS LATER ABLE TO REMOVE.". THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21018226 ↗
• MalfunctionDec 5, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, H9110, STERLING SPHERICAL BUR, 3.5 MM, WAS BEING USED ON 15NOV24 AND ¿THE DOCTOR USES THE SHAVER BURR UNTIL SHAVINGS BEGIN TO COME OUT, THE DOCTOR REMOVES THE INPUT AND REALIZES THAT A PIECE IS MISSING THAT WAS LEFT INSIDE THE PATIENT AND THAT HE WAS LATER ABLE TO REMOVE.". "THE SURGERY PERFORMED WAS AN ANKLE ARTHROSCOPY, THE PIECE OF THE BURR WAS REMOVED FROM THE PATIENT.". THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855562 ↗
• MalfunctionJun 28, 2023Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, H9110, 3.5MM STERLING SPHERICAL BUR, QTY 6 WAS BEING USED ON (B)(6) 23 DURING AN ARTHROSCOPIC PROCEDURE AND ¿IT WAS REPORTED THAT THAT WHEN AN ABRADER BAR WAS USED TO RESECT THE OSTEOPHYTE AT THE ANKLE AS, THE ABRADER BAR WAS BROKEN DURING THE SURGERY. THE BROKEN TIP WAS RECOVERED, THE NEW BAR WAS OPENED, AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS¿. THERE WAS NO IMPACT/INJURY FOR THE PATIENT OR USER. FURTHER ASSESSMENT FOUND THAT THERE WAS NO REPORT OF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215609 ↗
• MalfunctionJun 26, 2019Break; Break

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE H9110, 3.5MM STERLING SPHERICAL BUR, BROKE DURING USE ON (B)(6) 2019. THE INNER SHAFT OF THE PRODUCT WAS BROKEN. THERE WAS NO USER OR PATIENT INJURY OR IMPACT. THERE WAS NO REPORTED DELAY OF SURGERY. THE PROCEDURE WAS COMPLETED. THIS REPORT IS BEING RAISED BASED ON A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8734491 ↗
• MalfunctionFeb 15, 2019Break; Break

  THE ZIMMER BIOMET REPRESENTATIVE REPORTED THAT THE H9110, SHAVER BUR'S INNER SHAFT BROKE DURING AN ANKLE SURGERY ON (B)(6) 2018. THE BUR LOADED WITH NO ISSUES INTO THE HANDPIECE, THE BUR BROKE WHILE SHAVING AN OSTEOPHYTE. THERE WERE NO FRAGMENTS IN THE PATIENT, SO NOTHING HAD TO BE RETRIEVED. THERE WAS NO PATIENT INJURY AND NO SURGICAL 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 8345540 ↗
• MalfunctionJul 3, 2018Break; Break

  THIS DISTRIBUTOR REPORTED THAT THE H9110, 3.5MM STERLING SPHERICAL BUR, QTY 6, DRIVER TIP BROKE DURING A ARTHROSCOPIC FOOT SURGERY ON (B)(6) 2018 CAUSING APPROXIMATELY A 15-MINUTE DELAY. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR USER DURING THE EVENT. THE DEVICE WAS REPORTED AS HAVING NOT FALLEN INTO THE SURGICAL SITE; THEREFORE, THERE WERE NO COMPONENTS TO RETRIEVE. NO FURTHER INFORMATION WAS MADE AVAILABLE REGARDING THE PATIENT IN THIS CASE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658181 ↗
• MalfunctionJul 3, 2018Material Fragmentation; Material Fragmentation

  THIS DISTRIBUTOR REPORTED THAT THE H9110, 3.5MM STERLING SPHERICAL BUR, QTY 6, DRIVER TIP BROKE DURING A ARTHROSCOPIC FOOT SURGERY ON (B)(6) 2018 CAUSING APPROXIMATELY A 15-MINUTE DELAY. THERE WAS NO REPORT OF INJURY TO THE PATIENT OR USER DURING THE EVENT. THE DEVICE WAS REPORTED AS HAVING NOT FALLEN INTO THE SURGICAL SITE; THEREFORE, THERE WERE NO COMPONENTS TO RETRIEVE. NO FURTHER INFORMATION WAS MADE AVAILABLE REGARDING THE PATIENT IN THIS CASE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7658170 ↗