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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-jan-2026, a sales representative reported via email that an ar-7715 ucl internalbrace implant system experienced an issue during use.Specifically, the drill became cross-threaded with the drill guide, resulting in the guide snapping.The issue occurred during a ucl internalbrace procedure on (b)(6) 2026.No patient harm was reported.Additional information was received on 19-jan-2026: the issue occurred intraoperatively at the surgical site when the surgeon-initiated drilling for the first anchor hole.Although the patient¿s bone quality was described as good and young, the drill bit cross-threaded almost immediately upon contacting the patient's cortex.No product fragments were generated when the drill guide snapped.The procedure was completed using an additional ar-7715 ucl internalbrace implant system.The case was delayed approximately three minutes while the replacement kit was retrieved.No additional anesthesia was required, and no adverse effects were reported.
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: 24248104
• Report Number: 1220246-2026-00375
• Device Sequence Number: 9970291
• Product Code: MAI
• UDI-Device Identifier: 00888867220980
• UDI-Public: (01)00888867220980(11)251006(17)290930(10)15508868
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/13/2026

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: 15508868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• 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