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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 05/31/2024, it was reported by a sales representative via email that one of the swivelocks from an ar-7715 ucl internal brace implant system broke during insertion.All broken fragments were removed.The bone was prepped with the drill and tap from the kit.The case was completed by opening another ar-7715 ucl internal brace implant system.The drill was used again and cycled multiple times.A larger tap was used, double tapping, and was left to rest in the hole for 20 seconds.This was discovered during a ucl procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information g3, h3, h6.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: 19606570
• Report Number: 1220246-2024-06411
• Device Sequence Number: 12370635
• Product Code: MAI
• UDI-Device Identifier: 00888867220980
• UDI-Public: 00888867220980
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 06/13/2025

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: 15154570
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/06/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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