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

Model Number	TIGHTROPE® II ABS, IMPLANT
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that an ar-1588tn-20 tightrope® ii abs, implant was reported to have failed during use.This occurred on (b)(6) 2024 in(b)(6) hospital during a quad acl reconstruction.It was reported the tightrope was loaded onto a 14mm button and the surgeon attempted to tension the tightrope down to the button.One side shortened, the second side would not shorten.Traction of the suture above the button to no avail.The surgeon ended up tying the tightrope over the button and putting in a swivelock to back the acl up.The case was completed successfully using an additional point of fixation was used with a swivelock in the tibia.There was case involvement.
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.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 user error of the device due to excessive force used during suture passing/tightening /tensioning.

• 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: 20619982
• Report Number: 1220246-2024-08431
• Device Sequence Number: 8749305
• Product Code: MBI
• UDI-Device Identifier: 00888867371897
• UDI-Public: (01)00888867371897(11)231004(17)280930(10)15149742
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K231857
• 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): 07/07/2025

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: 15149742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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