MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC DL KNOTLESS CORKSCREW; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.75MM BC DL KNOTLESS CORKSCREW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/21/2025, it was reported by a sales representative via (b)(4) that an ar-1943bc dl knotless corkscrew device anchor broke in half when implanting.This was discovered during the case with no patient harm.Additional information was received on 10/27/25 from rep that these were both discovered during separate rotator cuff repairs.The green punch that was provided was used to prepare the bone socket for insertion.The bone quality of the patients were good and all fragments were retrieved.The device was not able to be sent in.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to use-related factors, including: off-axis insertion, improper bone preparation, and prying or leveraging the device with excessive force.

• Brand Name: 4.75MM BC DL KNOTLESS CORKSCREW
• 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: 23423751
• Report Number: 1220246-2025-04889
• Device Sequence Number: 9626403
• Product Code: MAI
• UDI-Device Identifier: 00888867409552
• UDI-Public: (01)00888867409552(11)250620(17)290531(10)15306889A
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K250526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 4.75MM BC DL KNOTLESS CORKSCREW
• Device Catalogue Number: AR-1943BC
• Device Lot Number: 15306889A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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