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

Model Number	PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
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 user error of the device due to excessive force being used when tensioning the sutures.
Event or Problem Description
On 3/15/2022, it was reported by a sales representative via email that twice, the fiberloop suture of ar-2290 proximal tenodesis implant system broke during insertion and pulling the tendon.This was discovered during a procedure on (b)(6) 2022.Additional information received on 3/17/2022: this was discovered during an open proximal bicep repair and was completed using another ar-2290 proximal tenodesis implant system from the same lot number.

• Brand Name: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• 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: 19257620
• Report Number: 1220246-2024-02862
• Device Sequence Number: 6614309
• Product Code: MBI
• UDI-Device Identifier: 00888867026698
• UDI-Public: 00888867026698
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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: 07/31/2026
• Device Model Number: PROXIMAL TENODESIS IMPLANT SYSTEM REV: 0
• Device Catalogue Number: AR-2290
• Device Lot Number: 14107225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown