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	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional code for box d.2: gat, suture, nonabsorbable, synthetic, polyethylene 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
A sales representative reported on behalf of a customer that the kmr2s, infinity aim meniscal repair device, 25° curved was used in an unnamed procedure on (b)(6) 2025, and ¿surgeon had two failures using item kmr2s lots 1486323 & 1503195.Both failures happened when tensioning the 2nd implant after deployment.Patient was unharmed and case was delayed 4 mins.¿.Further assessment found the "implant pulled through the caspule when tensioning".The "first implant seated correctly" and "implants were removed on the failed instruments" due to a failed deployment of the subsequent implant.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of 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 one device for this lot number and failure mode.(b)(4) the rate of failure would be (b)(4).Per the instructions for use, the user is advised to 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
A sales representative reported on behalf of a customer that the kmr2s, infinity aim meniscal repair device, 25° curved was used in an unnamed procedure on (b)(6) 2025, and ¿surgeon had two failures using item kmr2s lots 1486323 & 1503195.Both failures happened when tensioning the 2nd implant after deployment.Patient was unharmed and case was delayed 4 mins.¿.Further assessment found the "implant pulled through the capsule when tensioning".The "first implant seated correctly" and "implants were removed on the failed instruments" due to a failed deployment of the subsequent implant.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24055489
• Report Number: 1017294-2026-00009
• Device Sequence Number: 9745297
• Product Code: MBI
• UDI-Device Identifier: 20845854649906
• UDI-Public: (01)20845854649906(17)301027(10)1503195
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220186
• 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): 01/29/2026

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: 1503195
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic