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

Model Number TIGHTROPE, ABS, IMPLANT

Device Problem Break (1069)

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

Event Date 08/18/2022

Event Type  malfunction  

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.Visual inspection found the device is broken.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.Complaint was confirmed.

Event Description

On 08/29/2022, it was reported by an arthrex employee via email that an ar-1588tn tightrope broke when surgeon was tensioning.This was discovered during a case with no patient harm.

• Brand Name: TIGHTROPE, ABS, IMPLANT
• 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: emily shafer ; 8009337001
• MDR Report Key: 19132968
• MDR Text Key: 340722133
• Report Number: 1220246-2024-02112
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867019706
• UDI-Public: 00888867019706
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 04/18/2024

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, ABS, IMPLANT
• Device Catalogue Number: AR-1588TN
• Device Lot Number: 14938502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2022
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• 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