MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II BTB, RECON IB¿; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE® II BTB, RECON IB¿
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via email that a patient returned to the operating room for the removal of surgical hardware due to complications following an arthroscopic acl reconstruction performed approximately 6¿8 weeks ago.According to the surgeon, the patient had been recovering well until two weeks ago when drainage was noted from the tibial incision.In response, the patient underwent an operative knee washout, though no hardware was removed at that time.Following continued complaints of recurrent tibial drainage after the washout, the patient returned to the operating room on (b)(6) 2025.During the procedure, the ar-2324psl 4.75 peek-swivelock c, was fully removed from the tibia, along with the distal portion of the internalbrace suture.The implant was sent out for a culture.No further information was provided.Additional information was received on 4/24/2025: the original surgery took place on (b)(6) 2025.Both procedures were performed by the same surgeon.The infection identified was mssa.Additional information received on 5/16/2025: during the revision surgery, only the ar-2324pslc and a small portion of the ar-1588btb-ib tightrope ii btb, reconstruction with internalbrace suture that was in the tibia were removed.No further information was provided.
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 a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: TIGHTROPE® II BTB, RECON IB¿
• 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: 22166118
• Report Number: 1220246-2025-02420
• Device Sequence Number: 7957927
• Product Code: MBI
• UDI-Device Identifier: 00888867319677
• UDI-Public: 00888867319677
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE® II BTB, RECON IB¿
• Device Catalogue Number: AR-1588BTB-IB
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown