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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/10/2025, a sales representative reported via email that an ar-2290 proximal tenodesis implant system had an issue when inserting the button.The piece holding it on the button inserter broke off in the button, and they could not get it in there.There was no impact on the patient.This was discovered during a procedure, with no reported patient harm.Additional information has been requested.
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, h2, h3, h6, h11.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 is misuse due to the excessive force used to pry and/or leverage the device.

• 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: 21445376
• Report Number: 1220246-2025-00609
• Device Sequence Number: 7159170
• Product Code: MBI
• UDI-Device Identifier: 00888867026698
• UDI-Public: (01)00888867026698(11)230801(17)280531(10)15122864
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/25/2025

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: 15122864
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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