MAUDE Adverse Event Report: CONMED LARGO INFINITY AIM MENISCAL REPAIR DEVICE, 15 DEG. REVERSE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	KMR2R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional fda product code: 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 this issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the, kmr2r, infinity aim meniscal repair device, 15 deg.Reverse was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction with meniscal repair & posterolateral repair when it was reported ¿2nd cleat broke during tensioning.¿ further assessment questioning found that ¿peak cleats were not retrieved from surgical site, behind capsule.¿ the procedure was completed with the use of double ended sutures and a one-hour delay was reported during the procedure.There was no report of medical intervention or extended hospitalization required for the patient.The current status of the patient is ¿recovering¿.This report is being raised on the basis of injury due to patient retaining fragmentation of the device.
Additional Manufacturer Narrative
Additional fda product code: gat manufacturer narrative: the reported event of the cleat breaking is unconfirmed.Customer complaint cleat broke during tensioning was not confirmed.Examination of the returned used, item kmr2r could not confirm the reported problem.Removed both handles for one of the devices and could not find any discrepancies with assembled components.Both implants and the suture have been deployed for one of the returns.Sleeve adjuster and the wheel performed as intended during the test.No fault found with returned device.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 5 complaints, regarding 13 devices, for this device family and failure mode.During this same time frame 1,637 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 0.008.Per the instructions for use, the user is advised the following: 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 nay cause breakage of the device, implants and / or suture or premature failure.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the, kmr2r, infinity aim meniscal repair device, 15 deg.Reverse was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction with meniscal repair & posterolateral repair when it was reported ¿2nd cleat broke during tensioning.¿ further assessment questioning found that ¿peak cleats were not retrieved from surgical site, behind capsule.¿ the procedure was completed with the use of double ended sutures and a one-hour delay was reported during the procedure.There was no report of medical intervention or extended hospitalization required for the patient.The current status of the patient is ¿recovering¿.This report is being raised on the basis of injury due to patient retaining fragmentation of the device.

• Brand Name: INFINITY AIM MENISCAL REPAIR DEVICE, 15 DEG. REVERSE
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 15633801
• Report Number: 1017294-2022-00101
• Device Sequence Number: 14942515
• Product Code: MBI
• UDI-Device Identifier: 20845854649890
• UDI-Public: (01)20845854649890(17)250814(10)1264848
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/16/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2025
• Device Model Number: KMR2R
• Device Catalogue Number: KMR2R
• Device Lot Number: 1264848
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic