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	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/28/2025, a sales representative reported via email that an ar-8934bck 3.0mm knotless suturetak broke during use.After preparing the drill hole with a 2.4mm drill for the 3.0mm anchor, the surgeon tapped the anchor lightly twice and observed that the upper portion of the anchor body had broken.No fragments fell into the patient, and all broken pieces were successfully retrieved.The case was completed with a new anchor without issues.This was discovered during a lateral epicondylitis and tendon repair procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-8934bck, 3.0mm knotless suturetak, batch 15149882, was received for investigation.Visual evaluation noted that the anchor was damaged, along the last thread on the distal end.Functional testing was not performed due to damage to the device.The most likely cause is attributed to misuse due to misaligned insertion and prying/leveraging the device during use.

• 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: 22061121
• Report Number: 1220246-2025-02140
• Device Sequence Number: 18050895
• Product Code: MAI
• UDI-Device Identifier: 00888867380981
• UDI-Public: (01)00888867380981(11)231004(17)270930(10)15149882
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• 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): 09/24/2025

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: 15149882
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown