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	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2025
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 5/27/2025, a sales representative reported via email that metal shavings were found after drilling the sockets for the swivelocks in the ar-7715 ucl internal brace implant system.The issue appears to occur because the drill flutes extend past the soft tissue guide, making contact with the top of the guide if they are not perfectly aligned.This issue added some undesirable risk and time to the case.Per the sales representative, no further information is known about this event.
Event or Problem Description
Additional information was received on 06/24/2025: this event occurred during a ucl repair with interalbrace on (b)(6) 2025.The shavings were removed with suction and irrigation.The case was completed as normal after shavings were cleaned out, and a replacement ar-7715 ucl internal brace implant system was used to complete the case.There were no broken items, minus the shavings from the soft tissue protector.Extra time was needed during the case to clean out the metal shavings, estimated at approximately 5-10 minutes.It is uncertain if added anesthesia was administered.The lot number is unknown.The patient's bone quality was assessed as good, that of a young athlete.There were no photos taken of the event.
Additional Manufacturer Narrative
Additional information: b5, d6a, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 of the reported failure is user error in the device, which can be attributed to prying/leveraging, misalignment, and/or excessive force used during the drilling process.

• 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: 22287445
• Report Number: 1220246-2025-02543
• Device Sequence Number: 8467323
• Product Code: MAI
• UDI-Device Identifier: 00888867220980
• UDI-Public: 00888867220980
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 09/29/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/18/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown