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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2025
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 10/15/2025, a sales representative reported via email that an ar-2290 proximal tenodesis implant system experienced an issue during use.When attempting to deploy the sub-pec button, the button released prematurely.Attempts to re-thread the button onto the inserter were unsuccessful, as the threads would not hold the button in place despite multiple attempts.The implant was abandoned, and a new implant kit was opened to use a new button and inserter.After the procedure, additional attempts were made without success.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 10/20/2025: during a shoulder arthroscopy with sub-pectoral tenodesis performed on (b)(6) 2025, the button prematurely detached while being inserted into the patient.The button was removed, and an attempt was made to reattach it to the inserter, which was unsuccessful.As a result, the anchor was removed and not reinserted.No pieces broke off inside the patient due to the issue, and there were no retained fragments.The surgery experienced a brief delay of approximately 8 minutes due to efforts to re-thread the button.The surgeon ultimately discontinued use of the initial implant and opened a new one, completing the procedure without further issues.No additional anesthesia was administered, and no photographs were taken of the event.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpackaged ar-2290 batch 15484782 was received for evaluation.Visual inspection revealed no damage to the devices.However, the device was received without the button attached to the tip.A functional test was performed by inserting the needle inside the shaft the most likely cause of the reported failure is a user error.Direction for use dfu-0314-eor3_fmt_en.Biceps tenodesis implant systems g.Precautions 3.Loop and button should be properly oriented during passing and fixation, per technique guide, in order to function properly.

• 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: 23406316
• Report Number: 1220246-2025-04858
• Device Sequence Number: 14678002
• Product Code: MBI
• UDI-Device Identifier: 00888867026698
• UDI-Public: 00888867026698
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 02/20/2026

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: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Device Catalogue Number: AR-2290
• Device Lot Number: 15484782
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 02/20/2026
• 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