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	Insufficient Information (4580)
Date of Event	03/05/2025
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 03/06/2025, a sales representative reported via phone that an ar-7715 ucl internal brace implant system had two anchors stripped and broke when trying to insert into the bone.All pieces of the anchors were removed from the patient.There was an under 15-minute delay in the case with no added anesthesia administered to the patient.A second kit from the same lot successfully completed the case.This was discovered during an elbow ucl procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 21652283
• Report Number: 1220246-2025-01055
• Device Sequence Number: 9511303
• Product Code: MAI
• UDI-Device Identifier: 00888867220980
• UDI-Public: (01)00888867220980(11)240806(17)280731(10)15298323
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 09/10/2025

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: UCL INTERNAL BRACE IMPLANT SYSTEM
• Device Catalogue Number: AR-7715
• Device Lot Number: 15298323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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