MAUDE Adverse Event Report: ARTHREX, INC. ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM; POLYETHYLENE SYNTHETIC SUTURE

Model Number	ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-1288qt-100 acl fibertags suture disassociated from the needle.This occurred during an acl reconstruction on (b)(6) 2023, no fragments entered the patient and the was a slight delay while switching to another ar-1288qt-100 to complete the case.There was no patient effect reported.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation was not confirmed.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(s) for the reported failure can be a user error due to excessive forces shortening the suture strands.

• Brand Name: ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17577716
• Report Number: 1220246-2023-07575
• Device Sequence Number: 15553713
• Product Code: GAT
• UDI-Device Identifier: 00888867344716
• UDI-Public: 00888867344716
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K112990
• 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): 10/24/2024

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 Expiration Date: 09/30/2025
• Device Model Number: ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
• Device Catalogue Number: AR-1288QT-100
• Device Lot Number: 15057455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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