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

Catalog Number	CFBC-5503B
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 device, cfbc-5503b, suture anchor with three #2 (5 metric) hi-fi sutures,5.5 mm, was being used during a arthroscopy procedure on an unknown date when it was reported, ¿inserter broke, the tip came detached.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed without any reported delay.Further assessment found the inserter broke during use, a fragment fell into the patient and was retrieved using an arthroscopic grasper.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, cfbc-5503b, suture anchor with three #2 (5 metric) hi-fi sutures,5.5 mm, was being used during a arthroscopy procedure on an unknown date when it was reported, ¿inserter broke, the tip came detached.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed without any reported delay.Further assessment found the inserter broke during use, a fragment fell into the patient and was retrieved using an arthroscopic grasper.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.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 one complaint, regarding one device, for this device family and failure mode.During this same time frame (b)(4) 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).Per the instructions for use, the user is advised to inspect all instruments for damage prior to use.Avoid lateral loading while inserting the genesys crossft suture anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: GENESYS CROSSFT, HI-FI
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED; 525 french rd.; utica NY 13502
• 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: 24511313
• Report Number: 1017294-2026-00025
• Device Sequence Number: 10415365
• Product Code: MAI
• UDI-Device Identifier: 30845854042483
• UDI-Public: (01)30845854042483(17)281105(10)1503801
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: CFBC-5503B
• Device Lot Number: 1503801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic