MAUDE Adverse Event Report: CONMED STERLING; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	H9110
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised to continually check handpiece for overheating.If overheating is sensed, immediately discontinue use and return equipment for service.Overheating of the blade or bur may cause damage to the blade or bur and may cause burns or thermal necrosis.Do not use burs for plunge cutting.Injury or damage may occur.Do not stall handpieces, damage can occur.Running the shaver blade or bur without fluid flow (dry) may cause damage to the handpiece or may cause the bur hubs to melt due to excessive heat.Direct contact of the rotating cutting edge of shaver blades and burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices.If contact does occur, shaver blades can break, seize, or shed metal particles.Shaver blade or bur should be examined for damage and replaced if necessary.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: STERLING
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24753053
• Report Number: 1017294-2026-00039
• Device Sequence Number: 10330944
• Product Code: GFF
• UDI-Device Identifier: 10845854012802
• UDI-Public: (01)10845854012802(17)300313(10)144142
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H9110
• Device Lot Number: 1442142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic