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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/12/2025, a sales representative reported via email that the button from the inserter of an ar-2295 two-incision distal biceps implant system repeatedly fell off while loading or implanting the button.Another ar-2295 two-incision distal biceps implant system was opened, and the same issue occurred.This was discovered during a distal biceps procedure on (b)(6) 2025, with no reported patient harm.Additional information was requested on 11/17/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The failed device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in damage to the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 23707267
• Report Number: 1220246-2025-05325
• Device Sequence Number: 10641852
• Product Code: MBI
• UDI-Device Identifier: 00888867307421
• UDI-Public: 00888867307421
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/20/2026

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: 15502191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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