MAUDE Adverse Event Report: ARTHREX, INC. TWO INCISION DISTAL BICEPS IMPLANT KIT; NON-DEGRADABLE FIXATN FASTENER

Model Number	TWO INCISION DISTAL BICEPS IMPLANT KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/15/2024, it was reported by a sales representative via email that one of the inserters from an ar-2295 two incision distal biceps implant system snapped off the button when attempting to insert the button.The bone socket was prepped with the instrumentation from the kit.The button did not deploy, and all the fragments were removed.The case was completed using another ar-2295 two incision distal biceps implant system.This was discovered during a procedure on (b)(6) 2024.Additional information received on 4/19/2024: there was nothing loose inside the patient when the inserter snapped off as it as contained within the button.The case was delayed about two minutes and additional anesthesia was unnecessary.
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
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: TWO INCISION DISTAL BICEPS IMPLANT KIT
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 19287188
• Report Number: 1220246-2024-03098
• Device Sequence Number: 15358583
• Product Code: MBI
• UDI-Device Identifier: 00888867307421
• UDI-Public: 00888867307421
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K190288
• 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): 05/19/2025

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: TWO INCISION DISTAL BICEPS IMPLANT KIT
• Device Catalogue Number: AR-2295
• Device Lot Number: 15190972
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• 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