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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2021
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 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220246-2024-02450
• Device Sequence Number: 15358747
• Product Code: MAI
• UDI-Device Identifier: 00888867344921
• UDI-Public: 00888867344921
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: 05/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-1941P (PUNCH), AND AR-1941CT (GUIDE)
• Patient Age: 28 YR
• Patient Sex: Unknown