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 Codes	Positioning Failure (1158); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2025
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 10/29/2025, it was reported by a sales representative via email that an ar-1588btb-2j tightrope ii btb wouldn¿t stay cinched.The implant was left in the patient.This was discovered during a procedure on (b)(6) 2025.Additional information was received via email on 11/11/2025: the case was completed using an ar-4020c-09 fastthread biocomposite interference screw.The sales representative was unable to confirm whether the case was delayed or if additional anesthesia was required.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including improper bone preparation and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 23647046
• Report Number: 1220246-2025-05192
• Device Sequence Number: 17335774
• Product Code: MBI
• UDI-Device Identifier: 00888867319660
• UDI-Public: (01)00888867319660(11)250605(17)300531(10)15446879
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• 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): 03/06/2026

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: 15446879
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown