MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ® II BTB WITH DEPLOYING SUTURE; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ® II BTB WITH DEPLOYING SUTURE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/05/2025, a sales representative reported via (b)(4) that an ar-1588btb-2j card conversion failed.This occurred during an acl reconstruction/ knee scope the btb tightrope card conversion failed.The surgeon pulled the wire loop through and it was not threaded through the metal button.They opened a new btb tightrope ii to complete the case.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 the most likely cause.The most likely cause of the reported failure can be attributed to a manufacturing issue; however, due to the device was not returned, we are unable to confirm the reported event.

• Brand Name: TIGHTROPE ® II BTB WITH DEPLOYING SUTURE
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 22859894
• Report Number: 1220246-2025-03570
• Device Sequence Number: 20771106
• Product Code: MBI
• UDI-Device Identifier: 00888867319660
• UDI-Public: (01)00888867319660(11)250210(17)300131(10)15387122
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: TIGHTROPE ® II BTB WITH DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-2J
• Device Lot Number: 15387122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown