MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM; NON-DEGRADABLE FIXATN FASTENER

Model Number SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

It was reported on 8/24/2021 by a distributor rep that on (b)(6) 2021 two peek knotless suture-tak suture anchors were being used in a case.During use, both anchors failed and did not work.No further information, additional details requested.Additional information provided 8/27/2021: procedure being performed was an ankle instability repair.The tunnel was not made correctly prior to the insertion of the anchors so when pulling the sutures, the placement of the anchors was loose.The tunnels were prepared with a shaverdrill for 3.0 mm knotless suturetak, hard bone ar 1938dsr.The procedure was completed with an ar-1915snf.

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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Type of Device: NON-DEGRADABLE FIXATN FASTENER
• 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: 19088838
• MDR Text Key: 339929456
• Report Number: 1220246-2024-01980
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867024229
• UDI-Public: 00888867024229
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K180594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/11/2024

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: SUTR ANCH PEEK S-TAK KNOTLESS 3X12.7MM
• Device Catalogue Number: AR-1938PS
• Device Lot Number: 12162969
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2020
• 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