MAUDE Adverse Event Report: ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
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 a patient developed a cystic / ¿allergic-type¿ reaction after a scapholunate reconstruction performed with the internalbrace system.

• Brand Name: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 24792878
• Report Number: 1220246-2026-01966
• Device Sequence Number: 9727686
• Product Code: MBI
• UDI-Device Identifier: 00888867286801
• UDI-Public: (01)00888867286801(11)250429(17)300331(10)15428320
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K150648
• 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
• Report Date (Section B): 04/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H/W INTERNALBRACE LGMNT AUGMNT REPR KIT
• Device Catalogue Number: AR-8978-CP
• Device Lot Number: 15428320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown