MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT W/ DEPLOYING SUTURE; SMOOTH FIXATION PIN

Model Number	ACL TIGHTROPE RT W/ DEPLOYING SUTURE
Medical Device Problem Codes	Positioning Failure (1158); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/28/2023, it was reported by an arthrex subsidiary employee via email that an ar-1588rt-j acl tightrope rt would not tension.After the graft was implanted, the tibial fixation and tensioning were loose and after several pulls, the graft fell off.It was confirmed that the graft did not tear, so another ar-1588rt-j was used to complete fixation.This was discovered during a procedure on (b)(6) 2023.
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.Complaint allegation is 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 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 RT W/ DEPLOYING SUTURE
• Common Device Name: SMOOTH FIXATION PIN
• 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: 18394179
• Report Number: 1220246-2023-09613
• Device Sequence Number: 8723672
• Product Code: HTY
• UDI-Device Identifier: 00888867095533
• UDI-Public: 00888867095533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

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 RT W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 15111318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2023
• 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