MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/7/2024, it was reported by a sales representative via email that an ar-2350 knotless tension tight button implant system suture would not slide through the button when loading the suture through the button.The button ended up breaking off the inserter.The case was completed using another ar-2350 knotless tension tight button implant system.The patient was not affected.This was discovered during an open bicep procedure on (b)(6) 2024.Additional information received on 10/14/2024: this was discovered while the implant was in the patient.All broken fragments were removed.The case was delayed about twenty minutes; however, additional anesthesia was not needed.
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, h3, h6.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 for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• Brand Name: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• 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: 20524305
• Report Number: 1220246-2024-08242
• Device Sequence Number: 15746029
• Product Code: MBI
• UDI-Device Identifier: 00888867301924
• UDI-Public: (01)00888867301924(11)240402(17)290228(10)15228398
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K202444
• 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): 05/28/2025

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: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• Device Catalogue Number: AR-2350
• Device Lot Number: 15228398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2024
• 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