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

Model Number	KL FBTK RC W/ (BLU)FT & (W/BLK)#2 MTS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 6/7/2024, it was reported by a sales representative via phone that an ar-3653tsp knotless 2.6 fibertak rc sp soft anchor shuttling suture would not go through the anchor and would not tension.The anchor remained in the patient, and the sutures were removed.The case was completed by opening another ar-3653tsp knotless 2.6 fibertak with a slight delay in the case.Nothing broke inside the patient.This was discovered during an achilles speedbridge repair procedure for a haglund removal on (b)(6) 2024, with no reported patient harm.
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 for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging during insertion.

• Brand Name: KL FBTK RC W/ (BLU)FT & (W/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: jared engle ; 8009337001
• MDR Report Key: 19649028
• Report Number: 1220246-2024-06540
• Device Sequence Number: 7734216
• Product Code: MBI
• UDI-Device Identifier: 00888867370067
• UDI-Public: 00888867370067
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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 W/ (BLU)FT & (W/BLK)#2 MTS
• Device Catalogue Number: AR-3653TSP
• Device Lot Number: 15191368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown