MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE WITH FLIPCUTTER III; SMOOTH FIXATION PIN

Model Number FIBERTAG TIGHTROPE WITH FLIPCUTTER III

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2024

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.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

On 03/04/2024, it was reported by a sales representative via e-mail that (2) ar-1288rtt-fc3 fibertag tightrope with flipcutter iii had an excessive wobble when spun on the drill outside of the joint.This occurred during a quad auto acl reconstruction where the surgeon declined to use them, fearing the wobble would create a tunnel larger than what he wanted.The case continued using a flipcutter 2 to complete the procedure.

• Brand Name: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Type of Device: 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: jared engle ; 8009337001
• MDR Report Key: 18914112
• MDR Text Key: 337783274
• Report Number: 1220246-2024-01500
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867357624
• UDI-Public: 00888867357624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Device Catalogue Number: AR-1288RTT-FC3
• Device Lot Number: 15134867
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2023
• 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