MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ® II RT WITH DEPLOYING SUTURE; NON-DEGRADABLE FIXATN FASTENER

Model Number TIGHTROPE ® II RT WITH DEPLOYING SUTURE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2024

Event Type  malfunction  

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 Description

It was reported that during an anterior cruciate ligament reconstruction with meniscal repair surgery when reducing the tightope on the tibial end, the tightrope snapped at the locking mechanism.The surgery was finished successfully with a different device (ar-1588tb-3, lot: 15043427 tightrope® abs, button, round, concave, ø 11 mm).The abs button was used to tie the tightrope sutures over.A second surgery was required, which was performed on the on (b)(6) 2024.Update avoe 07-mar-2024 it was confirmed that the device tore during the surgery and the surgeon had to change technique to complete the surgery.The surgeon tied the tightrope sutures over the abs button on the tibial tunnel.No second surgery was required.

• Brand Name: TIGHTROPE ® II RT WITH DEPLOYING SUTURE
• Type of Device: 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: 18953808
• MDR Text Key: 338557454
• Report Number: 1220246-2024-01622
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00888867319714
• UDI-Public: 00888867319714
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K231857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/21/2024

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
• Device Operator: Health Professional
• Device Model Number: TIGHTROPE ® II RT WITH DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-2J
• Device Lot Number: 15115431
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1