MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BC SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 4.75MM BC SWVLK
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
An unknown issue with the reported device has occurred during a knee surgery.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.*** update cmackenbach (b)(6) *** further information was received.After right anterior cruciate ligament reconstruction surgery performed on (b)(6) 2022 the patient developed pain when running.A screw protrusion on the gerdy tubercle was suspected, which was confirmed with a mri scan on (b)(6) 2023.On (b)(6) 2024 another surgery was performed to remove the screw.

• Brand Name: DBL LOADED 4.75MM BC SWVLK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 23006168
• Report Number: 1220246-2025-03788
• Device Sequence Number: 16079299
• Product Code: MAI
• UDI-Device Identifier: 00888867264571
• UDI-Public: (01)00888867264571(11)220608(17)240531(10)14968978
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: AR-2324BCT-2-1
• Device Lot Number: 14968978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown