MAUDE Adverse Event Report: ARTHREX, INC. UCL INTERNAL BRACE IMPLANT SYSTEM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	UCL INTERNAL BRACE IMPLANT SYSTEM
Medical Device Problem Codes	Component Missing (2306); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 04-mar-2026, a sales representative reported via email that one of the swivelocks from an ar-7715 ucl internalbrace implant system was missing the anchor and included only an eyelet.Additionally, during the procedure, the drill guide warped.This issue was discovered during a ucl repair with internalbrace procedure on (b)(6) 2026.Additional information was received on 09-mar-2026: the drill guide warped gradually while drilling the pilot hole for the first anchor in the humerus.The deformation was limited to warping, with no chipping or material loss observed.The procedure was not delayed, and no additional anesthesia was required.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: UCL INTERNAL BRACE IMPLANT SYSTEM
• 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: 24690442
• Report Number: 1220246-2026-01655
• Device Sequence Number: 9771101
• Product Code: MAI
• UDI-Device Identifier: 00888867220980
• UDI-Public: (01)00888867220980(11)250513(17)290430(10)15435447
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: UCL INTERNAL BRACE IMPLANT SYSTEM
• Device Catalogue Number: AR-7715
• Device Lot Number: 15435447
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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
• Patient Sex: Unknown