MAUDE Adverse Event Report: CONMED INFINITY; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	KFB035
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
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.H3 other text: device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the kfb035 infinity femoral adjustable loop button device was being used during an acl reconstruction procedure on (b)(6) 2026 when it was reported ¿during a surgical procedure one was found damaged.¿.Further assessment found that the device fragmented into the surgical site and was removed with the use of a grasper and suture.The current status of the patient was reported as "good".The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation; however, photographic evidence has been provided.Root cause cannot be determined, however, based upon photos; 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 one device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 11 complaints, regarding 12 devices, 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 packaging for any damage prior to use.Remove items from sterile packaging using a septic technique and inspect prior to use.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 kfb035 infinity femoral adjustable loop button device was being used during an acl reconstruction procedure on (b)(6) 2026 when it was reported ¿during a surgical procedure one was found damaged.¿.Further assessment found that the device fragmented into the surgical site and was removed with the use of a grasper and suture.The current status of the patient was reported as "good".The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: INFINITY
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 24482329
• Report Number: 1017294-2026-00024
• Device Sequence Number: 18537040
• Product Code: MBI
• UDI-Device Identifier: 20845854649067
• UDI-Public: (01)20845854649067(11)250916(10)1493664
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K191204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: KFB035
• Device Lot Number: 1493664
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic