MAUDE Adverse Event Report: ARTHREX, INC. PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS; NON-DEGRADABLE FIXATION FASTENER

Model Number PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2021

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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.

Event Description

On 09/09/2021 it was reported by a sales representative via email that an ar-1941psv 3.9 mm knotless corkscrew®failed.The team used a reusable guide and punch and followed proper technique for insertion.After the surgeon passed the repair stitch from her first anchor, they heard a sound while she was tensioning and realized the anchor pulled out.She then removed the protruding anchor, cut out the suture, and left the second one since the construct could no longer be completed.The patient was 28 years old and appeared to have good bone.The doctor decided to not move forward with the remplissage after the anchor failed.Additional information provided 09/10/2021 the device will not be returning.The instruments used to prepare the bone were ar-1941p (punch), and ar-1941ct (guide).

• Brand Name: PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS
• Type of Device: NON-DEGRADABLE FIXATION 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: emily shafer ; 8009337001
• MDR Report Key: 19191539
• MDR Text Key: 341145780
• Report Number: 1220246-2024-02450
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867344921
• UDI-Public: 00888867344921
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS
• Device Catalogue Number: AR-1941PSV
• Device Lot Number: 11048270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AR-1941P (PUNCH), AND AR-1941CT (GUIDE)
• Patient Age: 28 YR