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

Catalog Number	H9110
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.H3 other text : device not yet received.
Event or Problem Description
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.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.If the device is returned, at a later date, the investigation may be updated and reanalyzed.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.A two-year lot history review shows a total of one device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised do not use burs for plunge cutting.Injury or damage may occur.Always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: STERLING
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF BUR
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 24711940
• Report Number: 1017294-2026-00034
• Device Sequence Number: 5989208
• Product Code: GFF
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEPMT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2026

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: 1490013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Sex: Unknown