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

Model Number	KL FBTK RC, (WH/BLK)TT & (BLU)#2 MTS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/21/2023, it was reported by a sales representative via phone that (2) ar-3600 fibertak anchors pulled out.The sutures were not balling up and appeared straight.The surgeon attempted to use an ar-3653sp knotless fibertak, and the shaft bent during insertion; did not break.The case was completed using a combination of ar-3600 fibertak and products from another manufacturer.This was discovered during a glenoid fracture procedure on (b)(6) 2023.
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.
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 causes of the reported failure are misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: KL FBTK RC, (WH/BLK)TT & (BLU)#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: 17941097
• Report Number: 1220246-2023-08219
• Device Sequence Number: 12380187
• Product Code: MBI
• UDI-Device Identifier: 00888867370043
• UDI-Public: 00888867370043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/07/2025

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: 15040327
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2023
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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