MAUDE Adverse Event Report: CONMED LARGO KPS ADJUSTABLE FREE LOOP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	KFL100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer, that the kfl100, kps adjustable free loop was being used during an acl & pcl with meniscus repair procedure on (b)(6) 2023 when it was reported ¿broke during the surgery timing.¿.Further assessment questioning found that the device did fragment and was removed from the surgical site.The procedure was completed without the use of an alternate device.There was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer, that the kfl100, kps adjustable free loop was being used during an acl & pcl with meniscus repair procedure on (b)(6) 2023 when it was reported ¿broke during the surgery timing.¿.Further assessment questioning found that the device did fragment and was removed from the surgical site.The procedure was completed without the use of an alternate device.There was no report of injury, medical intervention or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot 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.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 45 complaints, regarding 46 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 failure to size the diameter of the tunnel relative to the graft properly may result in suture breakage due to excessive force required to advance the graft.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: KPS ADJUSTABLE FREE LOOP
• 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: 18093083
• Report Number: 1017294-2023-00103
• Device Sequence Number: 6669897
• Product Code: MBI
• UDI-Device Identifier: 30845854649088
• UDI-Public: (01)30845854649088(17)280417(10)1311376
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K191204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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 Catalogue Number: KFL100
• Device Lot Number: 1311376
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic