MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW FT,3.5X 10MM; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,CRKSCRW FT,3.5X 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/07/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1915ft suture anchor broke.This occurred during a quadricipital knee tendon repair.When it was placed, it broke before it was completely in place.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the anchor had broken off of the shaft of the device.Refer to attachment.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: SUTR ANCH,CRKSCRW FT,3.5X 10MM
• 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: 22664950
• Report Number: 1220246-2025-03141
• Device Sequence Number: 3677789
• Product Code: MBI
• UDI-Device Identifier: 00888867022607
• UDI-Public: (01)00888867022607(11)221206(17)271130(10)15031013
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K061863
• 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): 09/30/2025

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: SUTR ANCH,CRKSCRW FT,3.5X 10MM
• Device Catalogue Number: AR-1915FT
• Device Lot Number: 15031013
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown