MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS BUTTON, 7MM; NON-DEGRADABLE FIXATION FASTENER

Model Number	TENODESIS BUTTON, 7MM
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	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/01/2022, it was reported by a sales representative via phone that a ar-2296 tenodesis button fell apart.This occurred during a sub-pectoral bicep tenodesis on (b)(6) /2022 when inserting the button into the drill hole the button was not attached and could not be re-attached.The case was completed using another ar-2296.There was no patient effected.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.However, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: TENODESIS BUTTON, 7MM
• Common Device Name: NON-DEGRADABLE FIXATION 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: 19257587
• Report Number: 1220246-2024-02861
• Device Sequence Number: 6463685
• Product Code: MBI
• UDI-Device Identifier: 00888867307438
• UDI-Public: 00888867307438
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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 Expiration Date: 06/30/2025
• Device Model Number: TENODESIS BUTTON, 7MM
• Device Catalogue Number: AR-2296
• Device Lot Number: 11381597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown