MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, MINI CORKSCREW FT; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, MINI CORKSCREW FT
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2021
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.Complaint confirmed, the ar-1319ft was received without an anchor assembled, however the device was returned out of package.The most likely cause of this failure is attributed to the mishandling of the device due to the as-received condition of the device (unpackaged).
Event or Problem Description
It was reported that the anchor on the ar-1319ft was not attached, when the new product was opened.Used a new product and the case is completed.No adverse effect on the patient.

• Brand Name: SUTURE ANCHOR, MINI CORKSCREW FT
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 19449136
• Report Number: 1220246-2024-04747
• Device Sequence Number: 8568001
• Product Code: HWC
• UDI-Device Identifier: 00888867008533
• UDI-Public: 00888867008533
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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: 07/31/2025
• Device Model Number: SUTURE ANCHOR, MINI CORKSCREW FT
• Device Catalogue Number: AR-1319FT
• Device Lot Number: 11428027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• 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