MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE WITH FIBERTAG, ABS; NON-DEGRADABLE FIXATN FASTENER

Model Number	ACL TIGHTROPE WITH FIBERTAG, ABS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/12/2024
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 12th september 2024, it was reported by a sales representative via email that for an ar-1588tnt, acl-fibertag®-tightrope® abs-implantat, 1 out of the 2 shortening limbs (white in colour) of the fibertag abs implant was unable to be shortened.This was detected during an acl reconstruction procedure on (b)(6) 2024.It was during the final step where the surgeon struggled and shortened 1 limb completely and was unable to shorten the other limb at all.This resulted in the abs button not sitting properly on the tibia.The procedure was completed successfully as the sutures were tied over the button instead of utilizing the knotless mechanism.
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: ACL TIGHTROPE WITH FIBERTAG, ABS
• 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: 20265930
• Report Number: 1220246-2024-07767
• Device Sequence Number: 8851052
• Product Code: MBI
• UDI-Device Identifier: 00888867308466
• UDI-Public: 00888867308466
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• 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: ACL TIGHTROPE WITH FIBERTAG, ABS
• Device Catalogue Number: AR-1588TNT
• Device Lot Number: 15126264
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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