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	Laceration(s) (1946)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
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, kmr2s, infinity aim meniscal repair device, 25° curved, was being used during an acl reconstruction procedure on (b)(6) 2025 when it was reported, ¿after placing the first implant the surgeon backs the needle about 1cm, when doing this the second implant dislodged without firing a second time.The device was not fired a second time, the evidence for this claim is that the pushrod was not yet deployed in front of the needle.It was still inside the needle.¿.The report also stated, ¿unnecessary damage to the meniscus.¿.Further assessment found that ¿there was more damage then just the puncturing of the needle.The first implant was successful, but the device failed when the surgeon tried to create enough slack for the second implant, around 1cm.When she did this the second implant just dislodged.The pushrod didn¿t cover the needle so i know that the surgeon didn¿t push twice.When removing the first implant the hole in the meniscus became bigger.This part is outside the normal use, the malfunction of the device forced the surgeon to remove the implant.¿.There was no report of medical intervention or hospitalization for the patient.The procedure was completed with an alternate device.The incident caused a 5-minute delay in the procedure.This report is being raised due to the reported injury of unnecessary damage to the meniscus.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, kmr2s, infinity aim meniscal repair device, 25° curved, was being used during an acl reconstruction procedure on (b)(6) 2025 when it was reported, ¿after placing the first implant the surgeon backs the needle about 1cm, when doing this the second implant dislodged without firing a second time.The device was not fired a second time, the evidence for this claim is that the pushrod was not yet deployed in front of the needle.It was still inside the needle.¿.The report also stated, ¿unnecessary damage to the meniscus.¿.Further assessment found that ¿there was more damage then just the puncturing of the needle.The first implant was successful, but the device failed when the surgeon tried to create enough slack for the second implant, around 1cm.When she did this the second implant just dislodged.The pushrod didn¿t cover the needle so i know that the surgeon didn¿t push twice.When removing the first implant the hole in the meniscus became bigger.This part is outside the normal use; the malfunction of the device forced the surgeon to remove the implant.¿.There was no report of medical intervention or hospitalization for the patient.The procedure was completed with an alternate device.The incident caused a 5-minute delay in the procedure.This report is being raised due to the reported injury of unnecessary damage to the meniscus.
Additional Manufacturer Narrative
Correction: d3 has been updated.Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.A device history review (dhr) found a non-conformance; however, it was not related to the manufacture of the product.A two-year lot history review shows a total of (b)(4) device for this lot number and failure mode.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 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.Avoid use in areas where sufficient amount of meniscal tissue is not present.We will continue to monitor per regulatory requirements to help ensure patient safety.

• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23703503
• Report Number: 1017294-2025-00121
• Device Sequence Number: 10672871
• Product Code: MBI
• UDI-Device Identifier: 20845854649906
• UDI-Public: (01)20845854649906(17)280904(10)1492322
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K220186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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 Catalogue Number: KMR2S
• Device Lot Number: 1492322
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic