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	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-4030c-09 biocomposite¿ interference screw was received for investigation.Visual inspection identified significant surface damage.The tip of the screw was fractured.Functional testing could not be performed due to the extent of the device's damage.The most likely cause for the reported failure includes: improper bone preparation, resulting in inadequate or uneven seating of the screw.Misaligned insertion, causing the screw to engage bone at an incorrect angle or trajectory.Prying or leveraging the device during insertion, with excessive mechanical stress, can lead to thread deformation or damage.
Event or Problem Description
On 1st sep 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-4030c-09, fastthread¿ biocomposite¿ interference screw 9 x 30 mm, its anchor broke during insertion.This was detected during an anterior cruciate ligament reconstruction of the knee joint surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-4030c-09.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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: 23094931
• Report Number: 1220246-2025-03949
• Device Sequence Number: 9226248
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: (01)00888867277663(11)240111(17)271231(10)15191905
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K202535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 01/29/2026

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: 15191905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown