MAUDE Adverse Event Report: ARTHREX, INC. KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS; ARTHROSCOPIC ACCESSORIES

Model Number	KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 11/9/2023, it was reported by a sales representative via email that an ar-3653ttsp knotless 2.6 fibertak rc sutures were frayed.When the surgeon pulled on the sutures, the repair stitch fell out.The case was completed without the medial mattress configuration.This was discovered during an rcr procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure is user error, pulling the suture strands again hard bone and/or instrument.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: emily shafer ; 8009337001
• MDR Report Key: 18278398
• Report Number: 1220246-2023-09242
• Device Sequence Number: 14966090
• Product Code: MBI
• UDI-Device Identifier: 00888867370081
• UDI-Public: 00888867370081
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K203268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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 Model Number: KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
• Device Catalogue Number: AR-3653TTSP
• Device Lot Number: 15133506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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