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

Model Number BTB TIGHTROPE

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2023

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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The probable cause of the event could not be determined from the information available and without device evaluation.As no further investigation was able to be performed no change in harm was identified; however, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.This complaint will be included in trending per wi-000100100.

Event Description

On 02/09/2023, it was reported by a sales representative via (b)(4) that a ar-1588btb btb tightrope® would not deploy correctly, the shuttle suture came untied.

• Brand Name: BTB 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: 19021442
• MDR Text Key: 339142530
• Report Number: 1220246-2024-01781
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019515
• UDI-Public: 00888867019515
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BTB TIGHTROPE
• Device Catalogue Number: AR-1588BTB
• Device Lot Number: 15003469
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2022
• 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