MAUDE Adverse Event Report: ARTHREX, INC. Ø9X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø9X 30MM BC IF SCRW, VENTED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
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 10/30/2025, an fda medwatch notification was received via email.A facility representative reported that an ar-4030c-09 fastthread biocomposite interference screw 9 x 30 mm broke.This incident occurred during a procedure.Additional information was received on 11/06/2025: during an arthroscopic right knee procedure for anterior cruciate ligament (acl) reconstruction on (b)(6) 2025, an issue occurred during the insertion of the interference screw.All detached fragments were identified and successfully retrieved from the patient during the procedure.The case was completed using a replacement ar-4030c-09 fastthread biocomposite interference screw (9 x 30 mm).The event resulted in a 10-minute delay to remove the broken screw and required an additional 10 minutes of anesthesia.No adverse effects to the patient have been reported as a result of this issue.
Additional Manufacturer Narrative
-complaint allegation is not confirmed.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.Dfu-0111-eo - g.Precautions - 2.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.7.Bio-absorbable interference screw only: if inserting the interference screw through the anteromedial portal, a knee flexion angle of 120° must be maintained throughout the entire insertion process.Not maintaining or changing the knee flexion angle during screw insertion may result in screw divergence or failure of the screwdriver.If achieving and maintaining the appropriate flexion angle is not possible or reasonable, a central transpatellar tendon portal should be considered for proper insertion.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper surgical technique/bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: Ø9X 30MM 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: 23568961
• Report Number: 1220246-2025-05085
• Device Sequence Number: 10155652
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: (01)00888867277663(11)240731(17)280630(10)15295595
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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: Ø9X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-09
• Device Lot Number: 15295595
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown