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

Model Number	ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via phone that an ar-1288qt-90 acl fibertag would not tighten.This occurred during an acl reconstruction on (b)(6) 2023, they inserted the implant, but it would not tighten.The device was cut out and replaced with another implant.There was no patient effect reported.
Additional Manufacturer Narrative
The complaint allegation was not confirmed.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 improper device technique.

• Brand Name: ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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: 17419522
• Report Number: 1220246-2023-07366
• Device Sequence Number: 8902206
• Product Code: GAT
• UDI-Device Identifier: 00888867344709
• UDI-Public: 00888867344709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 08/31/2025
• Device Model Number: ACL FIBERTAG® TIGHTROPE® IMPLANT SYSTEM
• Device Catalogue Number: AR-1288QT-90
• Device Lot Number: 13846861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown