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

Model Number	TIGHTROPE® II RT, RECON IB¿
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/10/2025, a sales representative reported via phone that an ar-1588rt-ib tightrope ii rt had an issue during an acl reconstruction procedure on (b)(6) 2025.When the surgeon used the device, the tightrope sutures broke inside the patient at final tensioning.The implant, together with all sutures, was removed from the patient, and there was no harm.Nothing other than the sutures had broken.The complaint device was available for return.Another ar-1588rt-ib tightrope ii rt with a different lot number, 15304212, was used to complete the procedure successfully.The case was delayed for 20 minutes, but no additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1588rt-ib/batch 15405766 was returned for investigation.Visual evaluation noted that the suture system was disassembled.The white sutures were torn and separated from the rest of the system.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening/tensioning.The complaint allegation is confirmed.

• Brand Name: TIGHTROPE® II RT, 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: 22414032
• Report Number: 1220246-2025-02744
• Device Sequence Number: 21326513
• Product Code: MBI
• UDI-Device Identifier: 00888867291638
• UDI-Public: (01)00888867291638(11)250318(17)300228(10)15405766
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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 RT, RECON IB¿
• Device Catalogue Number: AR-1588RT-IB
• Device Lot Number: 15405766
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown