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

Catalog Number	KMR2S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
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.
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 a meniscal repair procedure on (b)(6) 2025 when it was reported, "basically the second implant appears not to have been connected to the suture or it deployed early.Again, the surgeon had to search for the implants behind the knee but he could only find one.¿.An alternate device was used to complete the procedure causing a 5-minute delay.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported injury of foreign body left in patient.
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 a meniscal repair procedure on (b)(6) 2025 when it was reported, "basically the second implant appears not to have been connected to the suture or it deployed early.Again, the surgeon had to search for the implants behind the knee but he could only find one.¿.An alternate device was used to complete the procedure causing a 5-minute delay.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported injury of foreign body left in patient.
Additional Manufacturer Narrative
Examination of returned used, item kmr2s found no implants remaining on the device.Examinations found no issues with the device assembly process.Examination performed per print.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 17 complaints, regarding 21 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 that bending of the device may prevent proper insertion and / or damage the implants and / or suture / compromise needle structural integrity.The device should not be used as a lever.Improper insertion technique may cause breakage of the device, implants and / or suture or premature failure.Proper selection of the needle depth setting of the sleeve impacts ability to deploy implants successfully.Depressing the trigger prior to piercing the meniscus could deploy implants prematurely.Turning the wheel prematurely or in the wrong direction could cause the device to not perform as intended.Do not reload anchors into device.Reloading of anchors may cause repair device and/or implant damage.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 LARGO; 11311 concept blvd; largo FL 33773
• 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: 22157311
• Report Number: 1017294-2025-00059
• Device Sequence Number: 7484144
• Product Code: MBI
• UDI-Device Identifier: 20845854649906
• UDI-Public: (01)20845854649906(17)270506(10)1387019
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K220186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 1387019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: S&N FASTFIX.; S&N FASTFIX.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic