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

Model Number	BTB TIGHTROPE
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2022
Type of Reportable Event	Malfunction
Additional 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 device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when tensioning the sutures.
Event or Problem Description
On 1/10/2023, it was reported by a distributor via sems that (2) ar-1588btb btb tightrope locking mechanism failed.This was discovered during a pcl procedure on (b)(6) 2023.Additional information received on 1/10/2023: both instances of use with a graftlink, when passing the suture limb through the tightrope to finalize the construct, when pulled, the locking mechanism slipped under the button, and surgeon couldn't get it back to set the way it should.Case was completed with an ar-1588tn-1 tightrope abs.

• Brand Name: BTB TIGHTROPE
• Common Device Name: 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: 19352307
• Report Number: 1220246-2024-03528
• Device Sequence Number: 15274161
• Product Code: HTY
• UDI-Device Identifier: 00888867019515
• UDI-Public: 00888867019515
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: BTB TIGHTROPE
• Device Catalogue Number: AR-1588BTB
• Device Lot Number: 14224771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown