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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
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.Complaint confirmed.Upon visual inspection, it was noted that the anchor had come off of the device within the packaging.The most likely cause for the reported failure can be attributed to environmental due to damage incurred during shipping.
Event or Problem Description
On 7/21/2022, it was reported by an arthrex employee via email that an ar-1319ft mini corkscrew anchor had come off and could not be used.Another one was opened, from the same lot number, and the same thing happened.This was discovered upon opening package during a procedure on (b)(6) 2022.Additional information received on 7/22/2022: this was discovered during a pre-operative check so nothing broke inside 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: 19203556
• Report Number: 1220246-2024-02566
• Device Sequence Number: 20841759
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: SUTURE ANCHOR, MINI CORKSCREW FT
• Device Catalogue Number: AR-1319FT
• Device Lot Number: 14102113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 04/29/2024
• Date Device Manufactured: 09/09/2021
• 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