MAUDE Adverse Event Report: CONMED LARGO GENESYS CROSSFT, HI-FI; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	CFBC-6502B
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the cfbc-6502b was being used on (b)(6) 2025 and ¿dr.(b)(6) was the performing physician.He said he was made aware of the expiration during the case and elected to leave it implanted, with no issue to the patient.¿ there was no impact/injury or extended stay at the hospital for the patient.The patient is "recovering with no adverse conditions." this report is being raised due to the reported injury of implantation of an expired device.
Additional Manufacturer Narrative
Correction: b2, b5, h1 updated to malfunction; as this was incorrectly filed as an injury.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 1 report, regarding 1 device, for this device family and failure mode.During this same time frame 33,055 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 0.00003.Per the instructions for use, the user is advised the following: do not use beyond the expiration date listed on the label.The performance, safety, and/or sterility of the device cannot be assured beyond the expiration date.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the cfbc-6502b was being used on (b)(6) 2025 and ¿dr.Xxx was the performing physician.He said he was made aware of the expiration during the case and elected to leave it implanted, with no issue to the patient.¿ there was no impact/injury or extended stay at the hospital for the patient.The patient is "recovering with no adverse conditions." this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: GENESYS CROSSFT, HI-FI
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 23496689
• Report Number: 1017294-2025-00112
• Device Sequence Number: 9048329
• Product Code: MAI
• UDI-Device Identifier: 20845854042493
• UDI-Public: (01)20845854042493(17)250524(10)1247795
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K101100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2025
• Device Catalogue Number: CFBC-6502B
• Device Lot Number: 1247795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic