MAUDE Adverse Event Report: CONMED LARGO INFINITY AIM¿ SUTURE CUTTER AND SKID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	KSC20
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, ksc20, infinity aim suture cutter and skid was being used on (b)(6) 2022 during a knee arthroscopy, meniscal repair procedure and the ¿skid peeled off plastic during the case inside the patient.Plastic was removed.¿.There was no impact or injury to the patient.There was no report of medical/surgical intervention or prolonged hospitalization.The procedure was completed without an alternate device and there was no delay to the procedure.After further assessment it was discovered that "the needle rides down the sled into the joint protecting the cartilage.When this was done the needle drove into the "plastic" or whatever material it is and shred it off." the shaver and suction were used to retrieve the fragments.The patient is "doing great".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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.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 device, ksc20, infinity aim¿ suture cutter and skid was being used on (b)(6) 2022 during a knee arthroscopy, meniscal repair procedure and the ¿skid peeled off plastic during the case inside the patient.Plastic was removed.¿.There was no impact or injury to the patient.There was no report of medical/surgical intervention or prolonged hospitalization.The procedure was completed without an alternate device and there was no delay to the procedure.After further assessment it was discovered that "the needle rides down the sled into the joint protecting the cartilage.When this was done the needle drove into the "plastic" or whatever material it is and shred it off." the shaver and suction were used to retrieve the fragments.The patient is "doing great".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation, but photographic evidence has been provided that confirmed the reported event.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 1 reports, regarding 1 devices, for this device family and failure mode.During this same time frame 455 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 0.002.Per the instructions for use, the user is advised the following: preoperative and operating procedures, including knowledge of surgical technique are important considerations in the successful utilization of this device.Patient should be advised that product materials may cause allergic reactions including but not limited to, foreign body reaction, tissue irritation/inflammation or other allergic reactions.Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to use.Improper use of the device may cause premature cutting of the suture.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.Inspect instruments after use to ensure they have not been damaged.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: INFINITY AIM¿ SUTURE CUTTER AND SKID
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• 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: 15876821
• Report Number: 1017294-2022-00110
• Device Sequence Number: 11395932
• Product Code: LXH
• UDI-Device Identifier: 20845854649913
• UDI-Public: (01)20845854649913(17)231221(10)1251802
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 01/05/2023

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 Expiration Date: 12/21/2023
• Device Model Number: KSC20
• Device Catalogue Number: KSC20
• Device Lot Number: 1251802
• 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: 11/07/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic