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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 (b)(6) 2025, a sales representative reported via phone that qty.2 of an ar-1588btb-ib tightrope ii btb had an issue during an acl reconstruction procedure on (b)(6) 2025.When the surgeon tried to use the device, the locking suture mechanism ripped inside the patient; it broke the tightrope.That happened twice in a row.Nothing broke inside the patient, only the sutures, and there was no harm to the patient.Each time, the whole implant system was removed from the patient.Both complaint devices were discarded but a picture was taken.Another ar-1588btb-ib tightrope ii btb with lot number 15346826 was used to complete the procedure successfully.There was a case delay of 20 minutes and it could not be confirmed if additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Photographic evidence provided from the field of an unpackaged ar-1588btb-ib, with batch number 15319502, revealed that the sutures were damaged/frayed.Therefore, arthrex was able to deduce the cause of the reported failure can be attributed to user error of the device due to excessive force being used during the tightening of the suture system.

• 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: 21593996
• Report Number: 1220246-2025-00916
• Device Sequence Number: 20952103
• Product Code: MBI
• UDI-Device Identifier: 00888867319677
• UDI-Public: (01)00888867319677(11)240918(17)290831(10)15319502
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/11/2025

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, RECON IB¿
• Device Catalogue Number: AR-1588BTB-IB
• Device Lot Number: 15319502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown