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

Model Number BTB TIGHTROPE

Device Problem Difficult to Advance (2920)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

On (b)(6)/2023, it was reported by an arthrex employee via email that a btb tightrope chinese mesh got stuck and would not advance.The surgeon could not unlock the mesh, and the button failed to rise.The case was completed using another tightrope.This was discovered during a procedure on (b)(6)2023.Additional information requested.

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.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17441654
• MDR Text Key: 320225457
• Report Number: 1220246-2023-07384
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019515
• UDI-Public: 00888867019515
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112990
• 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: 08/02/2023

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: BTB TIGHTROPE
• Device Catalogue Number: AR-1588BTB
• Device Lot Number: 14543477
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 08/02/2023
• Date Device Manufactured: 11/15/2021
• 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