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

Model Number TIGHTROPE BUTTON EXTENDER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

On 3/29/2024, it was reported by a sales representative via email that an ar-1588btb-2j tightrope ii btb got suck and would not advance.The surgeon used an ar-1589rt tightrope button, and the button came dislodged after passing the far cortex of the femur.Getting the button reseated might have caused the tightrope ii btb to get tangled.The tightrope ii btb was cut, and another one was used to proceed with the procedure.The surgeon ended up drilling a new 4 mm hole and did not need to use the ar-1589rt tightrope button.This was discovered during an acl repair procedure on (b)(6) 2024.

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: TIGHTROPE BUTTON EXTENDER
• 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: 19175439
• MDR Text Key: 341691958
• Report Number: 1220246-2024-02339
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019812
• UDI-Public: 00888867019812
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231857
• 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: 04/24/2024

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 BUTTON EXTENDER
• Device Catalogue Number: AR-1589RT
• Device Lot Number: 15193904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2024
• 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