MAUDE Adverse Event Report: ARTHREX, INC. Ø10X 30MM BC IF SCRW, VENTED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	Ø10X 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	02/23/2026
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
It was reported that during the collateral ligament reconstruction, the tip of the screw broke off during insertion.The broken piece was retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-4030c-10, interference teno bio screw, batch 15460625, was received for investigation.Visual evaluation revealed a fractured distal end.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user-related factors such as off-axis insertion, prying, and leveraging the device with excessive force.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: Ø10X 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: 24608457
• Report Number: 1220246-2026-01429
• Device Sequence Number: 10199129
• Product Code: MAI
• UDI-Device Identifier: 00888867277670
• UDI-Public: (01)00888867277670(11)250703(17)290630(10)15460625
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 05/21/2026

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: Ø10X 30MM BC IF SCRW, VENTED
• Device Catalogue Number: AR-4030C-10
• Device Lot Number: 15460625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 02/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown