MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE® II ABS, IMPLANT; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE® II ABS, IMPLANT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1588tn-20 serial/batch number 15318322 was received for investigation.No functional testing was performed due to the damage to the device.Visual evaluation noted that the sutures were frayed.No sharp edges were observed on the button.There was also foreign matter lodged within the button.Per dfu-0147 g.Precautions 1.Acl/pcl/ btb/rt/abs tightrope only: excessive force on the shortening suture strands may break the strands and impair ability to fully seat the implant.Refer to the investigation photos.Complaint allegation is confirmed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the suture of the device broke while tightening the loop.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: TIGHTROPE® II ABS, IMPLANT
• 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: 21356273
• Report Number: 1220246-2025-00377
• Device Sequence Number: 9078583
• Product Code: MBI
• UDI-Device Identifier: 00888867371897
• UDI-Public: (01)00888867371897(11)240917(17)290831(10)15318322
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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 ABS, IMPLANT
• Device Catalogue Number: AR-1588TN-20
• Device Lot Number: 15318322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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