MAUDE Adverse Event Report: ARTHREX, INC. Ø8X 20MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø8X 20MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, an arthrex subsidiary employee reported via (b)(4) that an ar-4020c-08 07 x 20 mm fast thread biocomposite vented interference screw broke.It was necessary to use another 8x20 screw to complete the patellar acl procedure.No patient was affected.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: Ø8X 20MM BC IF SCRW, VENTED
• 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: 23377657
• Report Number: 1220246-2025-04795
• Device Sequence Number: 8815613
• Product Code: MAI
• UDI-Device Identifier: 00888867276963
• UDI-Public: (01)00888867276963(11)231103(17)271031(10)15162918
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K202535
• 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,Followup
• Report Date (Section B): 02/25/2026

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 Model Number: Ø8X 20MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4020C-08
• Device Lot Number: 15162918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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