MAUDE Adverse Event Report: ARTHREX, INC. PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0; NON-DEGRADABLE FIXATN FASTENER

Model Number	PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/3/2025, a sales representative reported via email that three ar-2290 proximal tenodesis implant systems experienced deployment issues.Specifically, the button on the inserter would not remain attached to the silver threaded portion.One button detached and fell to the floor, while two others failed to deploy correctly.One was eventually forced into place.These issues occurred during a biceps tenodesis procedure performed on (b)(6) 2025.
Additional Manufacturer Narrative
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 the most likely cause.The most likely cause of the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• 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: 23679791
• Report Number: 1220246-2025-05248
• Device Sequence Number: 9881719
• Product Code: MBI
• UDI-Device Identifier: 00888867026698
• UDI-Public: (01)00888867026698(11)250710(17)300430(10)15463852
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K123341
• 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
• Report Date (Section B): 12/01/2025

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: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Device Catalogue Number: AR-2290
• Device Lot Number: 15463852
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown