MAUDE Adverse Event Report: ARTHREX, INC. UCL INTERNAL BRACE IMPLANT SYSTEM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	UCL INTERNAL BRACE IMPLANT SYSTEM
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/12/2023, it was reported by a sales representative via phone that one of the peek swivelock anchors from an ar-7715 ucl internal brace implant system, broke during insertion, the other implanted successfully.Surgeon removed all the broken fragments.Another ar-7715 kit was opened, in which one of the peek swivelock anchors broke again and the other was implanted.All broken fragments were retrieved and an ar-2325bcc biocomposite swivelock was opened, but this one too broke during insertion.Case was completed by removing all broken fragments and using the combination of the peek swivelocks from the kits and additional sutures.This was discovered during an elbow ucl repair procedure on (b)(6) 2023.
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.
Additional Manufacturer Narrative
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(s) for the reported failure can be attributed to user error, improper bone preparation, misaligned insertion, or excessive forces through leveraging/prying the device.

• Brand Name: UCL INTERNAL BRACE IMPLANT SYSTEM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16263616
• Report Number: 1220246-2023-06186
• Device Sequence Number: 14672716
• Product Code: MAI
• UDI-Device Identifier: 00888867220980
• UDI-Public: 00888867220980
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/23/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown