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	Foreign Body In Patient (2687)
Date of Event	06/06/2025
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 06/17/2025, an arthrex employee reported via email an issue involving the ar-4030c-09 fastthread biocomposite interference screw.During the surgery, the surgeon began placing the ar-4030c-09 fastthread biocomposite interference screw into the tibia using the nitinol guide.After partially inserting the screw, the nitinol guide was removed, and the screw placement was completed.Upon removal of the driver, the tail of the screw detached and fell into the surgical field.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 06/26/2025.
Additional Manufacturer Narrative
Additional information: b5, d4, g3, h3, h6.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 of the device due to excessive force being used during insertion of the screw.
Event or Problem Description
Additional information was received on 07/11/2025: this occurred during a cruciate ligament reconstruction procedure on (b)(6) 2025.An ar-4030c-09 fastthread biocomposite interference screw from lot number 15173585 was used.While threading the implant, the distal portion of the screw fractured and broke within the bone tunnel.The screw remained inside the patient, and only the last thread of the screw came off.To complete the case, the surgeon reinforced the screw that split with an ar-2324pslc tilting anchor device in the form of a post.The bone socket was prepared using an 8.0 mm femoral drill (ar-1208l), a screwdriver ar-1996cd-1, and a screwdriver handle ar-1999.The patient was noted to have good bone quality.The event resulted in a 10-minute delay, with no additional anesthesia administered.No driver malfunction was reported, and no patient harm was noted following the procedure.

• 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: 22387121
• Report Number: 1220246-2025-02718
• Device Sequence Number: 18312914
• Product Code: MAI
• UDI-Device Identifier: 00888867277663
• UDI-Public: 00888867277663
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/07/2025

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: Ø9X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-09
• Device Lot Number: 15173585
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown