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

Catalog Number	KMR2S
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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 kmr2s, infinity aim meniscal repair device, 25° curved was being used on (b)(6) 2025 and the ¿¿devices were used with proper surgical technique and both failed.The patient was unharmed.Surgery was delayed 3 minutes.Repair was completed using stryker air.¿ per further assessment it was reported that "first implant deployed properly.2nd implant failed after deployment.Surgeon removed the implant.This occurred twice." there was no impact or injury to the patient.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 can not 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.A two-year lot history review shows a total of 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 76 reports, regarding 118 devices, for this device family and failure mode.During this same time frame 32,414 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 0.004.Per the instructions for use, the user is advised the following: exercise care in the use of these devices to minimize side or bending loads.Excessive forces applied to the device during use could cause the device to bend, break, or be unable to perform its intended function.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 kmr2s, infinity aim meniscal repair device, 25° curved was being used on 5dec25 and the ¿¿devices were used with proper surgical technique and both failed.The patient was unharmed.Surgery was delayed 3 minutes.Repair was completed using stryker air.¿ per further assessment it was reported that "first implant deployed properly.2nd implant failed after deployment.Surgeon removed the implant.This occurred twice." there was no impact or injury to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: INFINITY AIM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23905304
• Report Number: 1017294-2025-00132
• Device Sequence Number: 10024112
• Product Code: MBI
• UDI-Device Identifier: 20845854649906
• UDI-Public: (01)20845854649906(17)301023(10)1502596
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K220186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: KMR2S
• Device Lot Number: 1502596
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic