MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE; SMOOTH FIXATION PIN

Model Number ACL TIGHTROPE

Device Problem Blocked Connection (2888)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

It was reported that during an anterior cruciate ligament surgery the device got blocked and could not be used anymore.According to the surgeon there was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: ACL TIGHTROPE
• 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: 19007915
• MDR Text Key: 338951598
• Report Number: 1220246-2024-01740
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019614
• UDI-Public: 00888867019614
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACL TIGHTROPE
• Device Catalogue Number: AR-1588T
• Device Lot Number: 14325321
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/13/2021
• 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