MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM KNOTLESS SUTURETAK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.0MM KNOTLESS SUTURETAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/11/2025, a sales representative reported via email that the top portion of an ar-8934bck 3.0 mm knotless suturetak implant broke into pieces when the surgeon shuttled the knotless mechanism.A replacement implant was used to complete the procedure, and no patient harm was reported.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 06/24/2025: this occurred during an elbow epicondylitis procedure on (b)(6) 2025.All pieces of the broken implant were retrieved from the patient.There was no case delay, and no added anesthesia was administered.No adverse effects reported on or after the surgery.
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.The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted a damaged anchor.Refer to attachments.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 improper bone prep; misaligned insertion and/or prying/leveraging the device during insertion.

• Brand Name: 3.0MM KNOTLESS SUTURETAK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 22441479
• Report Number: 1220246-2025-02781
• Device Sequence Number: 7473338
• Product Code: MAI
• UDI-Device Identifier: 00888867380981
• UDI-Public: (01)00888867380981(11)231018(17)270930(10)15155850
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: 3.0MM KNOTLESS SUTURETAK
• Device Catalogue Number: AR-8934BCK
• Device Lot Number: 15155850
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown