MAUDE Adverse Event Report: ARTHREX, INC. BTB TIGHTROPE W/ DEPLOYING SUTURE; SMOOTH FIXATION PIN

Model Number	BTB TIGHTROPE W/ DEPLOYING SUTURE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/13/2025, it was reported by an arthrex subsidiary employee via email that during a case involving an ar-1588btb-j btb tightrope, the implant was prepared along with the bone block.As the button was advanced through the femoral tunnel, the suture attached to the implant broke, rendering the button unusable.As a result, the surgical team opted to change the fixation method.This was discovered during an acl procedure (b)(6) 2025.Additional information was received on 06/27/2025: the sutures broke while using a femoral suspension fixation method.Despite the breakage, the button remained secure in the patient, as the transfer suture was still intact.All components were removed from the patient before proceeding.To complete the case, the surgical team changed the fixation method from femoral suspension to femoral fixation using an interference screw, ar-4030c-08.The surgery was delayed by approximately 30 minutes; however, no additional anesthesia was required.
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.The complaint device was not received for evaluation.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 is user error, including improper device surgical technique.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Common Device Name: SMOOTH FIXATION PIN
• 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: 22455813
• Report Number: 1220246-2025-02796
• Device Sequence Number: 8315610
• Product Code: MBI
• UDI-Device Identifier: 00888867095366
• UDI-Public: (01)00888867095366(11)240206(17)290131(10)15203343
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-J
• Device Lot Number: 15203343
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown