MAUDE Adverse Event Report: CONMED LARGO 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	11/15/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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."."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.
Additional Manufacturer Narrative
Reported event of a piece is missing that was left inside the patient and that the surgeon was later able to remove is confirmed.The device has not been returned to date, but photographic evidence has been provided.If the device is returned, at a later date, the investigation may be updated and reanalyzed.Root cause cannot be determined, however, based upon the ifu; a possible cause of this event could be excessive force.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 (b)(4) for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 14 reports, regarding 14 devices, for this device family and failure mode.During this same time frame (b)(4) have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, (b)(4).Per the instructions for use, the user is advised the following: that running standard shaver blades above 6,000 rpm may generate excessive particulate.Only ultra series shaver blades are intended to run 12,000 rpm maximum speed.Do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.Always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damage.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
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.

• Brand Name: STERLING
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 20855562
• Report Number: 1017294-2024-00143
• Device Sequence Number: 12971374
• Product Code: GFF
• UDI-Device Identifier: 10845854012802
• UDI-Public: (01)10845854012802(17)290213(10)1370931
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 1370931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic