MAUDE Adverse Event Report: ARTHREX, INC. KL FBTK RC, (WH/BLK)TT & (BLU)#2 MTS; ARTHROSCOPE AND ACCESSORIES

Model Number	KL FBTK RC, (WH/BLK)TT & (BLU)#2 MTS
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
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 (b)(6) 2023, it was reported by a sales representative via email that an ar-3653sp knotless 2.6 fibertak rc fiberlink suture tore during insertion.This was discovered during a procedure on (b)(6) 2023.The case was completed using another ar-3653sp knotless 2.6 fibertak rc.Additional information received on (b)(6) 2023: this was discovered during an rcr procedure.Before using the new r-3653sp knotless 2.6 fibertak rc to complete the case, all the fragments from the previous fibertak were removed.The case was delayed a few seconds, and additional anesthesia was not needed.The patient suffered no negative effects on or after procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 method of bone preparation was not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: KL FBTK RC, (WH/BLK)TT & (BLU)#2 MTS
• Common Device Name: ARTHROSCOPE AND 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: 18378193
• Report Number: 1220246-2023-09535
• Device Sequence Number: 12666738
• Product Code: MBI
• UDI-Device Identifier: 00888867370043
• UDI-Public: 00888867370043
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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, (WH/BLK)TT & (BLU)#2 MTS
• Device Catalogue Number: AR-3653SP
• Device Lot Number: 15042610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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