MAUDE Adverse Event Report: CONMED LARGO BULLSEYE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	C8660
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, c8660, bullseye femoral guide, 8 mm/9 mm, was being used during an unknown procedure on (b)(6) 2025 when it was reported, ¿it was reported by surgical technologist that the guide broke inside the patient during the procedure.No fragments remained inside the patient; the surgeon was able to remove the piece that was in the patient's knee.¿.There was no report of injury, medical intervention, or hospitalization of the patient.Conmed was advised no further information is known.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.
Event or Problem Description
The customer reported that the device, c8660, bullseye femoral guide, 8 mm/9 mm, was being used during an unknown procedure on (b)(6) 2025 when it was reported, ¿it was reported by surgical technologist that the guide broke inside the patient during the procedure.No fragments remained inside the patient; the surgeon was able to remove the piece that was in the patient's knee¿.There was no report of injury, medical intervention, or hospitalization of the patient.Conmed was advised no further information is known.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of the returned used device item c8660 found guide tip broken off.Broken tip was not returned.Evaluation found signs of device misuse, due to grinding marks on the shaft tip.Item was inspected per print found no critical dimension issues.Root cause cannot be determined, however, based upon evaluation of the device and photos; a possible cause of this event could be excessive force.A two-year lot history review shows a total of one device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, for this device family and failure mode.During this same time frame 469 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: BULLSEYE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23007283
• Report Number: 1017294-2025-00100
• Device Sequence Number: 21458327
• Product Code: MDM
• UDI-Device Identifier: 10845854034293
• UDI-Public: 10845854034293
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: C8660
• Device Lot Number: 00022735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic