MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM PEEK SUTURETAK DL W/ SUTURETAPE; NON-DEGRADABLE FIXATN FASTENER

Model Number	3.0MM PEEK SUTURETAK DL W/ SUTURETAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
On 7/13/2023, it was reported by a sales representative via email that an ar-1934pst-2 peek suturetak suture broke, and the anchor pulled out during tensioning.This was discovered during a proximal hamstring procedure on (b)(6) 2023.Case completed using ar-1934pst-2.Delay less than 15 minutes.

• Brand Name: 3.0MM PEEK SUTURETAK DL W/ SUTURETAPE
• 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: 21112215
• Report Number: 1220246-2025-09296
• Device Sequence Number: 12647048
• Product Code: MBI
• UDI-Device Identifier: 00888867348714
• UDI-Public: 00888867348714
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140855
• 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
• Report Date (Section B): 01/09/2025

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 Expiration Date: 09/30/2025
• Device Model Number: 3.0MM PEEK SUTURETAK DL W/ SUTURETAPE
• Device Catalogue Number: AR-1934PST-2
• Device Lot Number: 11026667A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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